NCT05602935

Efficacy and Safety of SOX Regimen Combined With Camrelizumab as Neoadjuvant Treatment in Locally Advanced Gastric Cancer: a Phase II, Single-arm Study

Active, enrolled Phase 2 Last updated 28 September 2023

What this trial tests

Phase 2 trial testing Camrelizumab in Stomach Neoplasms in 29 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

16 September 2020

Primary endpoint
30 March 2022

30 December 2026

Quick facts

Lead sponsor	The Second Affiliated Hospital of Fujian Medical University
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	16 September 2020
Primary completion	30 March 2022
Estimated completion	30 December 2026
Sites	1 location across China

Drugs / interventions tested

• Camrelizumab — full drug profile →
• SOX — full drug profile →
• Surgery

Conditions studied

• Stomach Neoplasms — all drugs for Stomach Neoplasms →
• Digestive System Neoplasms — all drugs for Digestive System Neoplasms →
• Neoplasms — all drugs for Neoplasms →
• Digestive System Diseases — all drugs for Digestive System Diseases →

Sponsor

The Second Affiliated Hospital of Fujian Medical University

Who can join

18 and older, any sex, with Stomach Neoplasms or Digestive System Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single-arm, phase II study of camrelizumab combined with SOX regimen in subjects with resectable locally advanced gastric cancer. The patients will receive camrelizumab ,S-1 and oxaliplatin given every 3 weeks for 3 cycles as neoadjuvant therapy. After the surgery, adjuvant therapy which includes camrelizumab and SOX regimen will begin.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and safety of camrelizumab combined with oxaliplatin and S-1 as neoadjuvant treatment in locally advanced gastric or gastroesophageal junction cancer: A phase II, single-arm study.
   Zhong WJ, Lin JA, Wu CY, Wang J, et al · · 2024 · cited 14× · PMID 38400680 · DOI 10.1002/cam4.7006
2. Efficacy and safety of immunotherapy-based neoadjuvant regimens in locally advanced gastric cancer: a meta-analysis based on high-quality clinical trials.
   Liang C, Yu Z, Li R, Xu T, et al · · 2025 · cited 2× · PMID 40540446 · DOI 10.1097/js9.0000000000002815
3. Neoadjuvant PD-1/PD-L1 inhibitors combined with chemotherapy in gastric cancer and gastroesophageal junction adenocarcinoma: a systematic review and meta-analysis of single-arm studies.
   Leng J, Liu M, Wang Q, Jiang H, et al · · 2025 · cited 1× · PMID 40837578 · DOI 10.3389/fmed.2025.1625259
4. Perioperative immunotherapy in gastric cancer: walking a fine line between hope and caution.
   Cai X, Xiao X, Zhang C, Yu W. · · 2025 · PMID 41479907 · DOI 10.3389/fimmu.2025.1722749
5. Targeted therapies in neoadjuvant treatment for gastroesophageal cancer.
   Freile B, Rodriguez A, Catani G, Bortz M, et al · · 2025 · PMID 40606954 · DOI 10.3332/ecancer.2025.1921