Trials / Not Yet Recruiting
Not Yet RecruitingNCT07259473
Factors Influencing Immunotherapy Response in dMMR/MSI-H Gastric/Gastroesophageal Junction Adenocarcinoma
Factors Influencing Immunotherapy Response in Mismatch Repair Deficiency (dMMR) / Microsatellite Instability-High (MSI-H) Gastric/Gastroesophageal Junction Adenocarcinoma
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Shanghai Zhongshan Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
dMMR/MSI-H is a key molecular subtype of gastric cancer, found in 8-22% of cases. It is typically associated with older age, female sex, distal tumor location, and intestinal histology (Lauren classification). While this subtype predicts better survival in locally advanced disease, its prognostic role in metastatic settings is less clear. Notably, dMMR/MSI-H tumors are often resistant to conventional chemotherapy. Conversely, they demonstrate exceptional sensitivity to immunotherapy. This has led to effective strategies using immune checkpoint inhibitors, either alone or combined with chemotherapy, in both neoadjuvant and advanced disease settings. However, key challenges remain. Prospective data are largely from Western populations, leaving the efficacy in Asian patients-who bear a high disease burden-less defined. Furthermore, about half of dMMR/MSI-H patients exhibit primary or acquired resistance to immunotherapy. A deeper understanding of the tumor-immune dynamics during treatment is crucial to uncover resistance mechanisms and improve patient outcomes.
Conditions
- Gastric / Gastroesophageal Junction Adenocarcinoma
- Mismatch Repair Deficient or MSI-High Solid Tumors
- Immunotherapy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Immunotherapy | Drug: Immune checkpoint inhibitors (ICIs), specifically PD-1 antibodies, PD-L1 antibodies, PD-1/CTLA-4 bispecific antibodies, or PD-1/CTLA-4 combination therapy. Regimen: 4 treatment cycles. |
| DRUG | Induction chemotherapy | Drug: Oxaliplatin Regimen: 1 cycle Dosage: 130mg/m\^2 |
| PROCEDURE | D2 radical gastrectomy | Curative-intent D2 radical gastrectomy is scheduled 4-6 weeks after completion of the fourth cycle. |
Timeline
- Start date
- 2026-01-31
- Primary completion
- 2029-12-30
- Completion
- 2029-12-30
- First posted
- 2025-12-02
- Last updated
- 2026-01-07
Source: ClinicalTrials.gov record NCT07259473. Inclusion in this directory is not an endorsement.