Adebrelimab Combined With Induction Chemotherapy or SHR-8068 for Mismatch Repair-Deficient/Microsatellite Instability-High (dMMR/MSI-H) Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma：A Randomized, Non-comparative Phase 2 Study

ConditionsGastric Adenocarcinoma Gastroesophageal Adenocarcinoma Mismatch Repair Deficient or MSI-High Solid Tumors Immunotherapy

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorShanghai Zhongshan Hospital

About this trial

This is a randomized, non-comparative, open-label, two-arm phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy with adebrelimab plus induction chemotherapy versus adebrelimab plus SHR-8086 in patients with dMMR/MSI-H gastric or gastroesophageal junction adenocarcinoma.

Eligibility criteria

Qualifiers

Male or female, age ≥ 18 years

Pathologically confirmed gastric or gastro-oesophageal-junction adenocarcinoma (Siewert II and III only)

dMMR confirmed by IHC or MSI-H confirmed by PCR

Investigator-assessed potentially curative resection feasible before study entry

Disqualifiers

Tumour histology squamous-cell, neuro-endocrine, or other non-adenocarcinoma types

Unresectable disease (tumour-related or surgical contraindication) or subject refuses surgery

Tumour requiring transthoracic surgical approach

CNS metastases and/or carcinomatous meningitis

Trial design

Treatments tested in this trial

Adebrelimab
XELOX
SHR-8068
D2 radical gastrectomy

Treatment groups

30 Participants

are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov