NCT03939962

Camrelizumab Combined With FOLFOX Neoadjuvant Therapy for Resectable Gastric and Gastroesophageal Junctional Adenocarcinoma

Status unknown Phase 2 Last updated 26 January 2022

What this trial tests

Phase 2 trial testing SHR1210 combined with FOLFOX in Gastric Cancer in 60 participants. Status unknown.

Timeline

24 July 2019

Primary endpoint
30 May 2021

30 May 2024

Quick facts

Lead sponsor	Henan Cancer Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	24 July 2019
Primary completion	30 May 2021
Estimated completion	30 May 2024
Sites	1 location across China

Drugs / interventions tested

• SHR1210 combined with FOLFOX — full drug profile →

Conditions studied

• Gastric Cancer — all drugs for Gastric Cancer →

Sponsor

Henan Cancer Hospital

Who can join

Adults 18 to 73, any sex, with Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to observe the efficacy, safety, postoperative pathological response rate and survival benefit of immume checkpoint inhibitor PD-1 SHR1210 combined with chemotherapy in neoadjuvant therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma. In addition ，the investigators will explore the relationship between the immunophenotype of gastric cancer and the efficacy and drug resistance of immunotherapy combined with chemotherapy, and screen out biomarkers that can predict the efficacy of immunotherapy.

Publications & conference data

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

1. PD-1 blockade synergizes with oxaliplatin-based, but not cisplatin-based, chemotherapy of gastric cancer.
   Liu P, Chen J, Zhao L, Hollebecque A, et al · · 2022 · cited 50× · PMID 35769948 · DOI 10.1080/2162402x.2022.2093518
2. PD‑1/PD‑L1 immune checkpoint inhibitors in neoadjuvant therapy for solid tumors (Review).
   Tang Q, Zhao S, Zhou N, He J, et al · · 2023 · cited 19× · PMID 36866750 · DOI 10.3892/ijo.2023.5497
3. Neoadjuvant PD-1 blockade plus chemotherapy versus chemotherapy alone in locally advanced stage II-III gastric cancer: A single-centre retrospective study.
   Zhang X, Zhang C, Hou H, Zhang Y, et al · · 2023 · cited 17× · PMID 36934638 · DOI 10.1016/j.tranon.2023.101657
4. Predictive biomarkers and new developments of immunotherapy in gastric cancer: a 2023 update.
   Nie Y, Zhao W, Lu L, Zhou F. · · 2023 · cited 16× · PMID 37559976
5. Comprehensive multi-omics analysis of resectable locally advanced gastric cancer: Assessing response to neoadjuvant camrelizumab and chemotherapy in a single-center, open-label, single-arm phase II trial.
   Zhao Y, Li D, Zhuang J, Li Z, et al · · 2024 · cited 15× · PMID 38685486 · DOI 10.1002/ctm2.1674
6. A high interferon gamma signature of CD8⁺ T cells predicts response to neoadjuvant immunotherapy plus chemotherapy in gastric cancer.
   Li S, Li K, Tian F, Li H, et al · · 2022 · cited 11× · PMID 36685525 · DOI 10.3389/fimmu.2022.1056144
7. Combining neoadjuvant chemotherapy with PD-1/PD-L1 inhibitors for locally advanced, resectable gastric or gastroesophageal junction adenocarcinoma: A systematic review and meta-analysis.
   Yuan Z, Cui H, Wang S, Liang W, et al · · 2023 · cited 10× · PMID 36776290 · DOI 10.3389/fonc.2023.1103320
8. Evaluation of neoadjuvant immunotherapy in resectable gastric/gastroesophageal junction tumors: a meta-analysis and systematic review.
   Wang J, Tong T, Zhang G, Jin C, et al · · 2024 · cited 8× · PMID 38352873 · DOI 10.3389/fimmu.2024.1339757