NCT03878472

Neoadjuvant Immunotherapy for Resectable Gastric Cancer

Completed Phase 2 Last updated 16 December 2024

What this trial tests

Phase 2 trial testing SHR1210 in Gastric Cancer in 25 participants. Completed in 31 May 2024.

Timeline

1 April 2019

Primary endpoint
1 June 2022

31 May 2024

Quick facts

Lead sponsor	Qilu Hospital of Shandong University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	1 April 2019
Primary completion	1 June 2022
Estimated completion	31 May 2024
Sites	1 location across China

Drugs / interventions tested

• SHR1210 — full drug profile →
• Apatinib (Apatinib) — full drug profile →
• S1 — full drug profile →
• Oxaliplatin (Oxaliplatin) — full drug profile →

Conditions studied

• Gastric Cancer — all drugs for Gastric Cancer →

Sponsor

Qilu Hospital of Shandong University

Who can join

Adults 18 to 70, any sex, with Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

1. Target population: patients with resectable locally advanced gastric cancer (cT3-4bN+M0).
2. Primary objective:

(1) To evaluate the pathological remission rate (PRR) of PD-1 antibody monotherapy or in combination with anti-angiogenesis VEGFR2-TKI apatinib ± S1 ± Oxaliplatin in neoadjuvant (preoperative) treatment of resectable locally advanced gastric cancer.

(2) To evaluate the relationship between tumor pathological remission and biomarkers related to immunotherapy.

3\. Secondary objectives:

1. To evaluate the imaging objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) of PD-1 antibody alone or in combination with apatinib ± S1 ± Oxaliplatin in neoadjuvant therapy for locally advanced gastric cancer.
2. To evaluate the safety of PD-1 antibody or in combination with apatinib ± S1 ± Oxaliplatin in neoadjuvant (preoperative) treatment of resectable locally advanced gastric cancer.

Trial design: This is a monocenter, open, single arm, phase II study to evaluate the efficacy and safety of PD-1 antibody or in combination with apatinib ± S1 ± Oxaliplatin in neoadjuvant treatment of resectable locally advanced gastric cancer.

Publications & conference data

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

1. Neoadjuvant therapy with immune checkpoint blockade, antiangiogenesis, and chemotherapy for locally advanced gastric cancer.
   Li S, Yu W, Xie F, Luo H, et al · · 2023 · cited 184× · PMID 36596787 · DOI 10.1038/s41467-022-35431-x
2. Regulatory T cells in immune checkpoint blockade antitumor therapy.
   Zhang A, Fan T, Liu Y, Yu G, et al · · 2024 · cited 94× · PMID 39516941 · DOI 10.1186/s12943-024-02156-y
3. Endothelial cells in tumor microenvironment: insights and perspectives.
   Leone P, Malerba E, Susca N, Favoino E, et al · · 2024 · cited 90× · PMID 38426109 · DOI 10.3389/fimmu.2024.1367875
4. Current Status and Future Perspective of Immunotherapy in Gastrointestinal Cancers.
   Lu Z, Peng Z, Liu C, Wang Z, et al · · 2020 · cited 52× · PMID 34557714 · DOI 10.1016/j.xinn.2020.100041
5. 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
6. Predictive Biomarkers for Immunotherapy in Gastric Cancer: Current Status and Emerging Prospects.
   Hou W, Zhao Y, Zhu H. · · 2023 · cited 42× · PMID 37895000 · DOI 10.3390/ijms242015321
7. Immunotherapy and Cancer: The Multi-Omics Perspective.
   Donisi C, Pretta A, Pusceddu V, Ziranu P, et al · · 2024 · cited 29× · PMID 38542536 · DOI 10.3390/ijms25063563
8. Overcoming immunotherapy resistance in gastric cancer: insights into mechanisms and emerging strategies.
   Luo D, Zhou J, Ruan S, Zhang B, et al · · 2025 · cited 27× · PMID 39915459 · DOI 10.1038/s41419-025-07385-7