Clinical trial · Observational
Different Cycles of Neoadjuvant PD-1 Blockades + Chemotherapy for Advanced Gastric Cancer
The Comparison of Different Cycles of PD-1 Blockades Combined with Chemotherapy As Neoadjuvant Therapy for Patients with Advanced Gastric Cancer
NCT06798376CI-TRIAL-00085272recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to analyze the impact of different durations of neoadjuvant PD-1 inhibitor combined with chemotherapy on tumor regression and safety in patients with advanced gastric cancer. The main questions it aims to answer are: * Does the duration of neoadjuvant treatment influence tumor regression grading (TRG)? * How does treatment duration affect perioperative safety and clinical outcomes? Participants who have previously undergone neoadjuvant PD-1 inhibitor combined with chemotherapy followed by surgery as part of their routine medical care will have their clinical data retrospectively reviewed and analyzed.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ≤4 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy | Drug | — | UNRESOLVED |
| ≥5 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy | Drug | — | UNRESOLVED |
| Gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group A
- description
- The group A contains participants who received ≤4 cycles of neoadjuvant PD-1 inhibitor combined with chemotherapy and then received gastrectomy.
- interventionNames
- Drug: ≤4 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy
- Procedure: Gastrectomy
- label
- Group B
- description
- The group B contains participants who received ≥5 cycles of neoadjuvant PD-1 inhibitor combined with chemotherapy and then received gastrectomy.
- interventionNames
- Drug: ≥5 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy
- Procedure: Gastrectomy
Primary outcomes (1)
- measure
- Tumor Regression Grading (TRG)
- timeFrame
- Approximately 1 week after surgery (when the pathology examination report available)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Non-bedridden patients aged 18-90 years; * Histologically confirmed gastric or gastroesophageal junction adenocarcinoma by biopsy; * Evaluated as resectable advanced gastric cancer via CT, MRI, or laparoscopic exploration; * No prior anti-tumor treatments such as chemotherapy, radiotherapy, or immunotherapy; * No history of other malignancies within the past 5 years; * Received at least one cycle of PD-1 inhibitor combined with chemotherapy preoperatively, with no restrictions on the specific PD-1 inhibitor or chemotherapeutic agents; * Underwent radical gastrectomy after neoadjuvant therapy; * No severe underlying diseases. Exclusion Criteria: * Incomplete or inaccessible clinical and pathological data; * Postoperative pathology confirming non-gastric or non-gastroesophageal junction adenocarcinoma; * Distant metastases present prior to treatment; * Concurrent diagnosis of other malignancies.
References
Publications (16)
- BACKGROUNDHayashi T, Yoshikawa T, Sakamaki K, Nishikawa K, Fujitani K, Tanabe K, Misawa K, Matsui T, Miki A, Nemoto H, Fukunaga T, Kimura Y, Hihara J. Primary results of a randomized two-by-two factorial phase II trial comparing neoadjuvant chemotherapy with two and four courses of cisplatin/S-1 and docetaxel/cisplatin/S-1 as neoadjuvant chemotherapy for advanced gastric cancer. Ann Gastroenterol Surg. 2020 Jul 16;4(5):540-548. doi: 10.1002/ags3.12352. eCollection 2020 Sep. PMID 33005849
- BACKGROUNDYoshikawa T, Tanabe K, Nishikawa K, Ito Y, Matsui T, Kimura Y, Hirabayashi N, Mikata S, Iwahashi M, Fukushima R, Takiguchi N, Miyashiro I, Morita S, Miyashita Y, Tsuburaya A, Sakamoto J. Induction of a pathological complete response by four courses of neoadjuvant chemotherapy for gastric cancer: early results of the randomized phase II COMPASS trial. Ann Surg Oncol. 2014 Jan;21(1):213-9. doi: 10.1245/s10434-013-3055-x. Epub 2013 Jul 10. PMID 23838904
- BACKGROUNDLorenzen S, Gotze TO, Thuss-Patience P, Biebl M, Homann N, Schenk M, Lindig U, Heuer V, Kretzschmar A, Goekkurt E, Haag GM, Riera-Knorrenschild J, Bolling C, Hofheinz RD, Zhan T, Angermeier S, Ettrich TJ, Siebenhuener AR, Elshafei M, Bechstein WO, Gaiser T, Loose M, Sookthai D, Kopp C, Pauligk C, Al-Batran SE; AIO and SAKK Study Working Groups. Perioperative Atezolizumab Plus Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel for Resectable Esophagogastric Cancer: Interim Results From the Randomized, Multicenter, Phase II/III DANTE/IKF-s633 Trial. J Clin Oncol. 2024 Feb 1;42(4):410-420. doi: 10.1200/JCO.23.00975. Epub 2023 Nov 14. PMID 37963317
- BACKGROUNDSun W, Veeramachaneni N, Al-Rajabi R, Madan R, Kasi A, Al-Kasspooles M, Baranda J, Saeed A, Phadnis MA, Godwin AK, Olyaee M, Streeter N, Nagji A, Dai J, Williamson S. A phase II study of perioperative pembrolizumab plus mFOLFOX in patients with potentially resectable esophagus, gastroesophageal junction (GEJ), and stomach adenocarcinoma. Cancer Med. 2023 Aug;12(15):16098-16107. doi: 10.1002/cam4.6263. Epub 2023 Jun 16. PMID 37326317
- BACKGROUNDYuan SQ, Nie RC, Jin Y, Liang CC, Li YF, Jian R, Sun XW, Chen YB, Guan WL, Wang ZX, Qiu HB, Wang W, Chen S, Zhang DS, Ling YH, Xi SY, Cai MY, Huang CY, Yang QX, Liu ZM, Guan YX, Chen YM, Li JB, Tang XW, Peng JS, Zhou ZW, Xu RH, Wang F. Perioperative toripalimab and chemotherapy in locally advanced gastric or gastro-esophageal junction cancer: a randomized phase 2 trial. Nat Med. 2024 Feb;30(2):552-559. doi: 10.1038/s41591-023-02721-w. Epub 2024 Jan 2.