Status:
NOT_YET_RECRUITING
Immunotherapy Combined With Anti-angiogenic Therapy and Chemotherapy for Gastric/Gastroesophageal Junction Adenocarcinoma
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Gastric/Gastroesophageal Junction Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A single-arm, Phase II clinical study protocol of Apatolimab Tovolimab in combination with regorafenib and chemotherapy as first-line treatment for locally advanced or metastatic gastric/gastroesophag...
Eligibility Criteria
Inclusion
- Willing to participate in this study and has signed the informed consent form.
- 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
- 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.
- 8\. History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- 9\. Patients who have previously received anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies at any time.
Key Trial Info
Start Date :
September 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07148427
Start Date
September 20 2025
End Date
September 1 2028
Last Update
August 29 2025
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