NCT04819971

Study of Perioperative Chemotherapy Combined With Tislelizumab and Trastuzumab in the Treatment of GC/EGC

Status unknown Phase 2 Last updated 25 April 2023

What this trial tests

Phase 2 trial testing Tirelizumab in Stomach Cancer in 67 participants. Status unknown.

Timeline

1 December 2021

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	The First Affiliated Hospital of Zhengzhou University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	67
Start date	1 December 2021
Primary completion	31 December 2025
Estimated completion	31 December 2025
Sites	1 location across China

Drugs / interventions tested

• Tirelizumab
• Trastuzumab (trastuzumab) — full drug profile →
• Docetaxel (Docetaxel) — full drug profile →
• S1
• Oxaliplatin (Oxaliplatin) — full drug profile →

Conditions studied

• Stomach Cancer — all drugs for Stomach Cancer →

Sponsor

The First Affiliated Hospital of Zhengzhou University

Who can join

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

Sponsor's own description

Perioperative chemotherapy improves overall survival (OS) and disease-free survival (DFS) compared with surgery alone in patients with resectable gastric adenocarcinoma (GA) or gastro-oesophageal junction adenocarcinoma (GEJA). The addition of tislelizumab and trastuzumab to chemotherapy improves outcomes in patients with HER2-positive advanced gastric cancer (GC), and the investigators aimed to explore its role in the perioperative setting.

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. HER2-Positive Gastric Cancer: The Role of Immunotherapy and Novel Therapeutic Strategies.
   Pous A, Notario L, Hierro C, Layos L, et al · · 2023 · cited 32× · PMID 37511163 · DOI 10.3390/ijms241411403
3. HER2-Positive Gastric Cancer and Antibody Treatment: State of the Art and Future Developments.
   Scheck MK, Hofheinz RD, Lorenzen S. · · 2024 · cited 28× · PMID 38611014 · DOI 10.3390/cancers16071336
4. Perioperative Treatment in Gastric Cancer: A Fast-Changing Field.
   Costa M, Lopes Fernandes C, Magalhães H. · · 2024 · cited 4× · PMID 39682222 · DOI 10.3390/cancers16234036
5. 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
6. Bridging paradigms and shaping the future of resectable gastric cancer: a narrative review of the post-MATTERHORN era.
   Okemoto D, Nakayama I, Shitara K. · · 2026 · PMID 41809424 · DOI 10.1093/gastro/goag010
7. Perioperative immunotherapy combined with standard therapy for human epidermal growth factor receptor 2-positive locally advanced gastric cancer: A case report.
   Ma XT, Yao GY, Li JL, Wang XC, et al · · 2025 · PMID 41355925 · DOI 10.5306/wjco.v16.i11.112029
8. Additions of trastuzumab to preoperative chemotherapy or chemoimmunotherapy for patients with potentially resectable stage III to IV_B HER2-positive gastric cancer.
   Zhang X, Tian Y, Wang H, Song S, et al · · 2025 · PMID 40755752 · DOI 10.3389/fimmu.2025.1624943