NCT04997837

Study of Adjuvant Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy in Resected pN3 Gastric (G) or GEJ Adenocarcinoma

Recruiting now Phase 3 Last updated 10 August 2021

What this trial tests

Phase 3 trial testing PD-1 inhibitor in Gastric Cancer in 433 participants. Currently enrolling.

Timeline

21 July 2021

Primary endpoint
21 July 2027

21 October 2027

Quick facts

Lead sponsor	Fudan University
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	433
Start date	21 July 2021
Primary completion	21 July 2027
Estimated completion	21 October 2027
Sites	1 location across China

Drugs / interventions tested

• PD-1 inhibitor
• Oxaliplatin (Oxaliplatin) — full drug profile →
• Capecitabine (capecitabine) — full drug profile →
• Tegafur-gimeracil-oteracil potassium — full drug profile →
• 5-FU (5-fu) — full drug profile →
• Radiotherapy
• Chemotherapy

Conditions studied

• Gastric Cancer — all drugs for Gastric Cancer →

Sponsor

Fudan University

Who can join

18 and older, any sex, with Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with PD-1 inhibitors and chemoradiotherapy, in comparison with adjuvant chemotherapy only, in D2/R0 resected pN3 gastric or gastroesophageal junction adenocarcinoma. PD-1+CRT cohort: A total of 216 patients will receive 6 weeks of PD-1 inhibitors and chemotherapy, then receive concurrent chemoradiotherapy, followed by 6 weeks of PD-1 inhibitors and chemotherapy, finally receive maintenance treatment of PD-1 inhibitors until (maximum 1year after radiotherapy). CT cohort: A total of 217 patients will receive 6 months of chemotherapy. The disease-free survival(DFS), overall survival(OS) and adverse effects will be analyzed.

Publications & conference data

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

1. Recent developments in immunotherapy for gastrointestinal tract cancers.
   Chong X, Madeti Y, Cai J, Li W, et al · · 2024 · cited 52× · PMID 39123202 · DOI 10.1186/s13045-024-01578-x
2. 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
3. Immune checkpoint inhibitors in gastrointestinal malignancies: an Umbrella review.
   Noori M, Jafari-Raddani F, Davoodi-Moghaddam Z, Delshad M, et al · · 2024 · cited 17× · PMID 38183112 · DOI 10.1186/s12935-023-03183-3
4. Application of immune checkpoint inhibitors for resectable gastric/gastroesophageal cancer.
   Lin F, Chen Y, Huang B, Ruan S, et al · · 2024 · cited 4× · PMID 38783944 · DOI 10.3389/fphar.2024.1391562
5. The impact of aberrant lipid metabolism on the immune microenvironment of gastric cancer: a mini review.
   Chen S, Chen W, Xu T, Li J, et al · · 2025 · cited 3× · PMID 40901479 · DOI 10.3389/fimmu.2025.1639823
6. Adjuvant chemoradiotherapy plus PD-1 inhibitor for pN3 gastric cancer: a randomized, multicenter, Phase III trial.
   Yang W, Zhou M, Li G, Zhou C, et al · · 2024 · cited 1× · PMID 39545610 · DOI 10.1080/14796694.2024.2421156