Not yet recruiting NCT07151209
Immunotherapy Combined With Anti-angiogenic Therapy and Chemotherapy for Potentially Resectable MSI-H, dMMR Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Iparomlimab and Tuvonralimab combined with lenvatinib and SOX.
- Who it may be relevant to
- Registry conditions: Gastric or Gastroesophageal Junction Adenocarcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Multicenter, Open-label Phase II Single-arm Clinical Trial Protocol on the Efficacy and Safety of Lparomlimab and Tuvonralimab in Combination With Lenvatinib and SOX Chemotherapy in Potentially Resectable MSI-H, dMMR Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients
Overview
Efficacy and safety of Iparomlimab and Tuvonralimab in combination with lenvatinib and SOX chemotherapy in potentially resectable MSI-H, dMMR locally advanced gastric or gastroesophageal junction adenocarcinoma patients: A prospective, multicenter, open-label Phase II single-arm clinical trial
Interventions
- Drug Iparomlimab and Tuvonralimab combined with lenvatinib and SOX
Iparomlimab and Tuvonralimab:5 mg/kg Q3W lenvatinib:8 mg/day orally SOX：oxaliplatin (130 mg/m² Q3W intravenous infusion), and S-1 (40 mg/m² BID orally on days 1-14)
Primary outcome measures
- Pathological complete response (pCR) rate [Time frame: Up to approximately 2 years]
Secondary outcome measures (7)
- Major pathological response (MPR) rate [Time frame: Up to approximately 2 years]
- R0 resection rate [Time frame: Up to approximately 2 years]
- Objective response rate (ORR) [Time frame: Up to approximately 2 years]
- Event-free survival (EFS) [Time frame: Up to approximately 2 years]
- 12-month, 24-month, and 36-month event-free survival rates Disease-free survival (DFS) [Time frame: Up to approximately 3 years]
- Overall survival (OS) [Time frame: Up to approximately 5 years]
- 12-month, 24-month, and 36-month overall survival rates [Time frame: Up to approximately 3 years]
Eligibility criteria
Inclusion criteria
- Able to understand and agree to comply with study requirements and the assessment schedule, and voluntarily sign the written informed consent form (ICF) before any trial-related procedures are implemented;
- Age greater than 18 years, regardless of gender. Histologically confirmed unresectable locally advanced or metastatic G/GEJ adenocarcinoma.
- No prior systemic treatment for unresectable locally advanced or metastatic G/GEJ adenocarcinoma. Previous neoadjuvant and/or adjuvant therapy is acceptable, but all systemic treatments must have been completed at least 6 months prior to the diagnosis of unresectable or metastatic disease.
- PD-L1 combined positive score (CPS) less than 1 as determined by tissue testing.
- At least one measurable lesion according to RECIST 1.1 criteria.
- ECOG performance status 0-1.
- Life expectancy >3 months.
- Adequate organ and marrow function:
Exclusion criteria
- 1\. Known HER2-positive expression (immunohistochemistry \[IHC\] 3+ or 2+ with a fluorescence in situ hybridization HER2:CEP17 ratio ≥2).
- Presence of other malignancies within 5 years prior to treatment, with the exception of adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, locally treated prostate cancer, and ductal carcinoma in situ (hormone therapy for non-metastatic prostate cancer or breast cancer is permitted).
- Known central nervous system metastases and/or carcinomatous meningitis.
- Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction.
- Hypertension that cannot be controlled with antihypertensive medications (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg).
- History of bleeding within 4 weeks prior to screening, with any bleeding event graded as ≥3 according to CTCAE 5.0.
- Thrombotic events (arterial or venous) within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis (excluding previously thrombosed veins deemed healed by the investigator), and pulmonary embolism.
- History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- Patients who have previously received anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies at any time.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07151209 · QL-GasC-QIBA-3011