Immunotherapy Combined With Anti-angiogenic Therapy and Chemotherapy for Gastric/Gastroesophageal Junction Adenocarcinoma

NCT07148427 | Not Yet Recruiting Phase 2

• 1 other identifier: QL-GasC-QIBA-3007
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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/gastroesophageal junction adenocarcinoma

Conditions

Gastric/Gastroesophageal Junction Adenocarcinoma

Keywords

regorafenib; chemotherapy; Iparomlimab and Tuvonralimab

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Up to approximately 2 years

Secondary Outcomes (5)

• Progression-free survival (PFS)

  Up to approximately 2 years

• Disease control rate (DCR)

  Up to approximately 2 years

• Duration of response (DoR)

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 5 years

• The incidence and severity of adverse events (AE) during the study period (Safety)

  Up to approximately 2 years

Study Arms (1)

Iparomlimab and Tuvonralimab combination with regorafenib and chemotherapy

EXPERIMENTAL

Drug: Iparomlimab and Tuvonralimab combination with regorafenib and chemotherapy

Interventions

Iparomlimab and Tuvonralimab combination with regorafenib and chemotherapy DRUG

Iparomlimab and Tuvonralimab：5mg/kg，Intravenous infusion，Q3W regorafenib：80mg，oral administration once daily from Day 1 to Day 14 chemotherapy：XELOX or SOX

Iparomlimab and Tuvonralimab combination with regorafenib and chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Interventions

regorafenib; Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Hao Wu, Professor

CONTACT

+8613913855335

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: August 29, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share