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

Official title

A Single-arm, Phase II Clinical Study Protocol of Lparomlimab and Tuvonralimab in Combination With Regorafenib and Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Overview

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

Interventions

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

Primary outcome measures

• Objective response rate [Time frame: Up to approximately 2 years]

Secondary outcome measures (5)

• Progression-free survival (PFS) [Time frame: Up to approximately 2 years]
• Disease control rate (DCR) [Time frame: Up to approximately 2 years]
• Duration of response (DoR) [Time frame: Up to approximately 2 years]
• Overall survival (OS) [Time frame: Up to approximately 5 years]
• The incidence and severity of adverse events (AE) during the study period (Safety) [Time frame: Up to approximately 2 years]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

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: NCT07148427 · QL-GasC-QIBA-3007

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗