. 2026 Jan 29:92:103768.

doi: 10.1016/j.eclinm.2026.103768. eCollection 2026 Feb.

Solvent-based or nab-paclitaxel plus ramucirumab for pretreated gastric cancer with peritoneal dissemination and prespecified biomarker analysis (P-SELECT/WJOG10617G): a randomised phase 2 trial in Japan

Kenro Hirata^{1

2}, Yasuo Hamamoto^{2

3}, Hirokazu Shoji⁴, Hiroki Hara⁵, Chihiro Kondoh⁶, Hisateru Yasui⁷, Takeshi Kajiwara⁸, Eishi Baba⁹, Takayuki Ando¹⁰, Naotoshi Sugimoto¹¹, Hisato Kawakami^{12

13}, Hiroo Katsuya¹⁴, Michitaka Nagase¹⁵, Yoshiyuki Yamamoto¹⁶, Kenichi Yoshimura¹⁷, Masahiko Ando¹⁸, Chiyo K Imamura¹⁹, Kentaro Yamazaki²⁰, Shuichi Hironaka²¹, Kei Muro²²

Affiliations

¹ Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
² Keio Cancer Center, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
³ Department of Medical Oncology, Institute of Science Tokyo, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.
⁴ Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
⁵ Department of Gastroenterology, Saitama Cancer Center, 780 Komuro, Ina-machi, Kita-Adachi-gun, Saitama, 362-0806, Japan.
⁶ Department of Medical Oncology, Toranomon Hospital, 2-2-2, Toranomon, Minato-ku, Tokyo, 105-8470, Japan.
⁷ Department of Medical Oncology, Kobe City Medical Center General Hospital, 2-1-1, Minatojima, Minamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan.
⁸ Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, 160 Kou, Minamiumemoto-machi, Matsuyama-shi, Ehime, 791-0280, Japan.
⁹ Department of Oncology and Social Medicine, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
¹⁰ Third Department of Internal Medicine, University of Toyama, 2630 Sugitani, Toyama-shi, Toyama, 930-0194, Japan.
¹¹ Department of Medical Oncology, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka-shi, Osaka, 541-8567, Japan.
¹² Department of Medical Oncology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan.
¹³ Department of Clinical Oncology, Tohoku University Graduate School of Medicine, Seiryo-machi 4-1, Aoba, Sendai, Miyagi, 980-8575, Japan.
¹⁴ Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, 5-1-1 Nabeshima, Saga City, Saga, 849-0937, Japan.
¹⁵ Department of Medical Oncology, Saku Central Hospital Advanced Care Center, 3400-28 Nakagomi, Saku, 385-0051, Japan.
¹⁶ Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, 2-1-1 Amakubo, Tsukuba, Ibaraki, 305-8576, Japan.
¹⁷ Department of Biostatistics, Medical Center for Translational and Clinical Research, Hiroshima University Hospital, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan.
¹⁸ Department of Advanced Medicine, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.
¹⁹ Advanced Cancer Translational Research Institute, Showa Medical University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan.
²⁰ Division of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
²¹ Department of Medical Oncology, Kyorin University Faculty of Medicine, 6-20-2 Shinkawa, Mitaka-shi, Tokyo, 181-8611, Japan.
²² Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya-shi, Aichi, 464-8681, Japan.

PMID: 41660367
PMCID: PMC12876630
DOI: 10.1016/j.eclinm.2026.103768

Solvent-based or nab-paclitaxel plus ramucirumab for pretreated gastric cancer with peritoneal dissemination and prespecified biomarker analysis (P-SELECT/WJOG10617G): a randomised phase 2 trial in Japan

Kenro Hirata et al. EClinicalMedicine. 2026.

. 2026 Jan 29:92:103768.

doi: 10.1016/j.eclinm.2026.103768. eCollection 2026 Feb.

Authors

Affiliations

¹ Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
² Keio Cancer Center, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
³ Department of Medical Oncology, Institute of Science Tokyo, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.
⁴ Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
⁵ Department of Gastroenterology, Saitama Cancer Center, 780 Komuro, Ina-machi, Kita-Adachi-gun, Saitama, 362-0806, Japan.
⁶ Department of Medical Oncology, Toranomon Hospital, 2-2-2, Toranomon, Minato-ku, Tokyo, 105-8470, Japan.
⁷ Department of Medical Oncology, Kobe City Medical Center General Hospital, 2-1-1, Minatojima, Minamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan.
⁸ Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, 160 Kou, Minamiumemoto-machi, Matsuyama-shi, Ehime, 791-0280, Japan.
⁹ Department of Oncology and Social Medicine, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
¹⁰ Third Department of Internal Medicine, University of Toyama, 2630 Sugitani, Toyama-shi, Toyama, 930-0194, Japan.
¹¹ Department of Medical Oncology, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka-shi, Osaka, 541-8567, Japan.
¹² Department of Medical Oncology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan.
¹³ Department of Clinical Oncology, Tohoku University Graduate School of Medicine, Seiryo-machi 4-1, Aoba, Sendai, Miyagi, 980-8575, Japan.
¹⁴ Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, 5-1-1 Nabeshima, Saga City, Saga, 849-0937, Japan.
¹⁵ Department of Medical Oncology, Saku Central Hospital Advanced Care Center, 3400-28 Nakagomi, Saku, 385-0051, Japan.
¹⁶ Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, 2-1-1 Amakubo, Tsukuba, Ibaraki, 305-8576, Japan.
¹⁷ Department of Biostatistics, Medical Center for Translational and Clinical Research, Hiroshima University Hospital, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan.
¹⁸ Department of Advanced Medicine, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.
¹⁹ Advanced Cancer Translational Research Institute, Showa Medical University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan.
²⁰ Division of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
²¹ Department of Medical Oncology, Kyorin University Faculty of Medicine, 6-20-2 Shinkawa, Mitaka-shi, Tokyo, 181-8611, Japan.
²² Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya-shi, Aichi, 464-8681, Japan.

PMID: 41660367
PMCID: PMC12876630
DOI: 10.1016/j.eclinm.2026.103768

Abstract

Background: Gastric cancer (GC) with peritoneal dissemination remains a challenge with poor prognosis and limited treatment options. We aimed to compare solvent-based paclitaxel (sb-PTX) + ramucirumab (RAM) vs. nanoparticle-albumin-bound paclitaxel (nab-PTX) + RAM as second-line therapy for unresectable or recurrent GC with peritoneal dissemination.

Methods: This prospective, randomised, open-label, multicentre phase 2 trial was conducted at 58 centres within the West Japan Oncology Group (WJOG) in Japan. Eligible participants were patients with histologically-confirmed GC with peritoneal dissemination refractory or intolerant to first-line therapy. Patients were randomised 1:1 to receive sb-PTX + RAM or nab-PTX + RAM. Primary endpoint was overall survival (OS); key secondary endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), safety, and protocol-specified biomarker analyses including the assessment of stromal caveolin-1 (Cav-1) expression by immunohistochemistry on archival tumour specimens. The data cutoff for the analysis presented herein was January 27, 2021. This trial was registered in the Japan Registry of Clinical Trials (jRCTs031180022).

Findings: Between Oct 1, 2018, and Jan 27, 2020, 105 patients were assigned to sb-PTX + RAM (n = 53) or nab-PTX + RAM (n = 52). Median follow-up was 18.1 months. Median OS was 8.1 months with sb-PTX + RAM and 7.2 months with nab-PTX + RAM (HR [nab-PTX + RAM vs. sb-PTX + RAM], 0.960; 95% CI, 0.621-1.484; P = 0.631). Median PFS was 5.1 vs. 3.9 months (HR [nab-PTX + RAM vs. sb-PTX + RAM], 0.965; 95% CI, 0.642-1.450; P = 0.893). ORR was 20.7% vs. 20.0% (P = 0.993), and DCR was 77.4% vs. 63.5% (P = 0.150), with sb-PTX + RAM and nab-PTX + RAM. Grade≥3 neuropathy occurred in 7.5% with sb-PTX + RAM and 17.6% with nab-PTX + RAM, and febrile neutropenia in 11.3% vs. 5.9%. In biomarker analysis, OS and PFS improved stepwise with increasing Cav-1 expression in patients receiving nab-PTX + RAM (P = 0.007, P = 0.012); no such association was observed with sb-PTX + RAM. Among patients with high stromal Cav-1 expression (IHC score 3+), nab-PTX + RAM showed some evidence of improved OS compared with sb-PTX + RAM (HR [nab-PTX + RAM vs. sb-PTX + RAM], 0.371; 95% CI, 0.130-1.060; P = 0.055). The interaction between Cav-1 expression and treatment arm showed a non-significant trend (HR for interaction, 0.364; 95% CI, 0.115-1.152; P = 0.086), consistent with this finding.

Interpretation: Treatment with nab-PTX + RAM did not meet the prespecified threshold (HR < 0.90) for promising efficacy in patients with GC and peritoneal dissemination. High stromal Cav-1 expression was associated with improved efficacy of nab-PTX + RAM. Future studies should prospectively validate the predictive value of stromal Cav-1 in patients receiving nab-PTX + RAM.

Funding: Taiho Pharmaceutical Co. Ltd.

Keywords: Caveolin-1; Gastric cancer; Nanoparticle albumin-bound paclitaxel (nab-paclitaxel); Peritoneal dissemination; Predictive biomarker; Second-line therapy.

PubMed Disclaimer

Conflict of interest statement

Kenro Hirata declares–Consulting or advisory role: Daiichi Sankyo. Honoraria: Eli Lilly Japan, Taiho Pharmaceutical, Ono Pharmaceutical, Takada Pharmaceutical, Daiichi Sankyo, Bristol Myers Squibb, Merck Biopharma, MSD, Chugai Pharmaceutical, AstraZeneca, Astellas Pharma, Zeria Pharmaceutical, Novartis, BeiGene, Guardant Health. Research funding: Taiho Pharmaceutical, Ono Pharmaceutical, Bristol Myers Squibb, EA Pharma, Pfizer, Amgen. Yasuo Hamamoto declares–Research funding: Ono Pharmaceutical. Hirokazu Shoji declares–Research funding: Amgen, Astellas Pharma, MSD, Ono Pharmaceutical, Takeda Pharmaceutical. Hiroki Hara declares–Consulting or advisory role: Boehringer Ingelheim, Chugai Pharmaceutical, Daiichi Sankyo. Honoraria: Chugai Pharmaceutical, Taiho Pharmaceutical, Merck Biopharma, Yakult Pharmaceutical Industry, Eli Lilly Japan, Ono Pharmaceutical, Takeda Pharmaceutical, Bristol Myers Squibb, MSD, Daiichi Sankyo, Miyarisan Pharmaceutical, Nippon Kayaku, Astellas Pharma. Research funding: AstraZeneca (Inst), Merck Biopharma (Inst), MSD (Inst), Ono Pharmaceutical (Inst), Taiho Pharmaceutical (Inst), Daiichi Sankyo (Inst), Astellas Pharma (Inst), Bayer Yakuhin (Inst), Amgen (Inst), Chugai Pharmaceutical (Inst), Janssen Oncology (Inst), ALX Oncology (Inst), Bristol Myers Squibb (Inst), Jazz Pharmaceuticals (Inst), AbbVie (Inst), Henlius (Inst). Chihiro Kondoh declares–Consulting or advisory role: Astellas Pharma. Honoraria: Takeda Pharmaceutical, Chugai Pharmaceutical, Bristol Myers Squibb, MSD, Eisai, Janssen Pharmaceutical, Sanofi, Astellas Pharma, Merck, Kyowa Kirin, Daiichi Sankyo, Ono Pharmaceutical. Research funding: Astellas Pharma, Daiichi Sankyo, MSD. Hisateru Yasui declares–Consulting or advisory role: Ono Pharmaceutical. Honoraria: Bayer Yakuhin, Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, Ono Pharmaceutical, Taiho Pharmaceutical, Takeda Pharmaceutical, Yakult Honsha. Research funding: Astellas Pharma, Daiichi Sankyo, MSD, Ono Pharmaceutical. Takeshi Kajiwara declares–Honoraria: Chugai Pharmaceutical, Eli Lilly Japan, Bristol Myers Squibb, Taiho Pharmaceutical, Ono Pharmaceutical, Daiichi Sankyo. Eishi Baba declares–Consulting or advisory role: Astellas Pharma, AstraZeneca, Daiichi Sankyo. Honoraria: Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, Merck Biopharma, Ono Pharmaceutical, Taiho Pharmaceutical, Eisai, Miyarisan Pharmaceutical, MSD, Sanofi, Tsumura, Yakult Pharmaceutical Industry. Research funding: Chugai Pharmaceutical, Taiho Pharmaceutical. Takayuki Ando declares–Consulting or advisory role: Astellas Pharma. Honoraria: Daiichi Sankyo, Eli Lilly Japan, Bristol Myers Squibb, Ono Pharmaceutical, Taiho Pharmaceutical, Astellas Pharma. Naotoshi Sugimoto declares–Honoraria: Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, MSD. Research funding: Astellas Pharma, BeiGene, Chugai Pharmaceutical, Daiichi Sankyo, Sumitomo Pharma, Eli Lilly Japan, MSD, Ono Pharmaceutical, Solasia Pharma, Taiho Pharmaceutical. Hisato Kawakami declares–Consulting or advisory role: Astellas Pharma, Daiichi Sankyo, Bristol Myers Squibb, Eli Lilly Japan, Ono Pharmaceutical, Taiho Pharmaceutical. Honoraria: AstraZeneca, Bayer Yakuhin, Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, Merck Biopharma, MSD, Ono Pharmaceutical, Taiho Pharmaceutical, Takeda Pharmaceutical, Yakult Pharmaceutical Industry. Research funding: Chugai Pharmaceutical, Daiichi Sankyo, Eisai. Hiroo Katsuya declares–Honoraria: Bristol Myers Squibb. Michitaka Nagase declares–None. Yoshiyuki Yamamoto declares–Honoraria: Astellas, AstraZeneca, Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Incyte, Lilly, MSD, Nippon Kayaku, Novartis, Ono Pharmaceutical, Taiho Pharmaceutical, Takeda Pharmaceutical, Yakult Honsha. Research funding: Asahi Kasei, Daiichi Sankyo. Kenichi Yoshimura declares–Consulting or advisory role: BrightPath Biotherapeutics, Nippon Shinyaku. Honoraria: AstraZeneca, Boehringer Ingelheim, Chugai Pharmaceutical, Eisai, Eli Lilly Japan, Nippon Kayaku, Novartis, Otsuka Pharmaceutical, Taiho Pharmaceutical, Takeda Pharmaceutical. Masahiko A. declares–Research funding: Kyowa Kirin. Chiyo K. Imamura declares–Honoraria: Kyowa Kirin. Research funding: Eli Lilly Japan, Otsuka Pharmaceutical. Kentaro Yamazaki declares–Honoraria: Bayer Yakuhin, Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, Merck Serono, MSD, Ono Pharmaceutical, Sanofi, Taiho Pharmaceutical, Takeda Pharmaceutical, Yakult Honsha. Research funding: Taiho Pharmaceutical. Shuichi Hironaka declares–Consulting or advisory role: Bristol Myers Squibb, Daiichi Sankyo, Ono Pharmaceutical. Honoraria: AstraZeneca, Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, Merck Biopharma, Nippon Kayaku, Ono Pharmaceutical, Sanofi, Taiho Pharmaceutical, Takeda Pharmaceutical, Tsumura, Yakult Honsha. Research funding: Astellas Pharma, AstraZeneca, Boehringer Ingelheim, Chugai Pharmaceutical, Kyowa Kirin, Ono Pharmaceutical, Pfizer, Sanofi, Shionogi, Taiho Pharmaceutical, Takeda Pharmaceutical, Toyama Chemical, Yakult Honsha. Kei Muro declares–Consulting or advisory role: Amgen, AstraZeneca, Ono Pharmaceutical, Astellas Pharma, Daiichi Sankyo, Roche Diagnostics, Chugai Pharmaceutical. Honoraria: MSD, Bristol Myers Squibb, Ono Pharmaceutical, Eli Lilly Japan, Takeda Pharmaceutical, Daiichi Sankyo, Taiho Pharmaceutical. Research funding: Astellas Pharma, Amgen, Sanofi, Novartis, Parexel International, PRA Health Sciences, Taiho Pharmaceutical, MSD, Chugai Pharmaceutical, Ono Pharmaceutical.

Figures

**Fig. 2**
Kaplan–Meier curves of overall survival and progression-free survival. (A) Overall survival. (B) Progression-free survival. MST, median survival time; HR, hazard ratio (nab-paclitaxel (nab-PTX) plus ramucirumab (RAM) vs. solvent-based paclitaxel (sb-PTX) plus RAM; HR < 1 favours nab-PTX + RAM); CI, confidence interval.

**Fig. 3**
Stromal Caveolin-1 (Cav-1) expression and survival outcome in gastric cancer. (A–D) Representative immunohistochemistry (IHC) images of stromal Cav-1 expression. (A) IHC Score 0: negative staining. (B) IHC Score 1+: weak to moderate staining, less intense than vascular endothelium. (C) IHC Score 2+: staining intensity comparable to vascular endothelium. (D) IHC Score 3+: strong staining, more intense than vascular endothelium. (E–H) Kaplan–Meier survival curves stratified by stromal Cav-1 expression. (E) Overall survival (OS) in the solvent-based paclitaxel (sb-PTX) + ramucirumab (RAM) arm. (F) Progression-free survival (PFS) in the sb-PTX + RAM arm. (G) OS in the nab-paclitaxel (nab-PTX) + RAM arm. (H) PFS in the nab-PTX + RAM arm.

**Fig. 4**
Overall survival stratified by stromal Caveolin-1 (Cav-1) expression in both treatment arms. (A) Immunohistochemistry (IHC) score 0/1+, (B) IHC score 2+, (C) IHC score 3+.

**Supplementary Figure S1**
Kaplan–Meier curves for time to treatment failure in the solvent-based paclitaxel (sb-PTX) + ramucirumab (RAM) and nab-paclitaxel (nab-PTX) + RAM arms.

**Supplementary Figure S2**
AForest plots of subgroup analyses comparing solvent-based paclitaxel (sb-PTX) + ramucirumab (RAM) and nab-paclitaxel (nab-PTX) + RAM for overall survival (OS) and progression-free survival (PFS). (A) Subgroup analysis for OS. (B) Subgroup analysis for PFS. Hazard ratios (HRs) and 95% confidence intervals (CIs) are shown. Horizontal bars represent 95% CIs.

**Supplementary Figure S3**
Distribution of patients by relative dose intensity categories of taxanes.

**Supplementary Figure S4**
Mean relative dose intensity of taxanes by treatment cycle in both arms. Error bars indicate 95% confidence intervals (CIs).

**Supplementary Figure S5**
Distribution of patients by relative dose intensity categories of ramucirumab.

**Supplementary Figure S6**
Mean relative dose intensity of ramucirumab by treatment cycle in both arms. Error bars indicate 95% confidence intervals (CIs).

**Supplementary Figure S7**
Longitudinal assessment of patient-reported peripheral neuropathy using the FACT/GOG-NTX (version 4.0) subscale score. Error bars indicate 95% confidence intervals (CIs).

**Supplementary Figure S8**
Distribution of plasma trough concentrations (C_min) of ramucirumab in the solvent-based paclitaxel (sb-PTX) + ramucirumab (RAM) and nab-paclitaxel (nab-PTX) + RAM arms. Boxes represent the interquartile range (IQR; 25th–75th percentiles); horizontal lines within boxes indicate the median; whiskers denote the most extreme data points within 1.5 × IQR; circles represent outliers beyond this range; and “X” marks indicate the mean. NS, not significant.

See this image and copyright information in PMC

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Solvent-based or nab-paclitaxel plus ramucirumab for pretreated gastric cancer with peritoneal dissemination and prespecified biomarker analysis (P-SELECT/WJOG10617G): a randomised phase 2 trial in Japan

Affiliations

Solvent-based or nab-paclitaxel plus ramucirumab for pretreated gastric cancer with peritoneal dissemination and prespecified biomarker analysis (P-SELECT/WJOG10617G): a randomised phase 2 trial in Japan

Authors

Affiliations

Abstract

Conflict of interest statement

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