NCT07289997

Iparomlimab and Tuvonralimab Combined With Apatinib and Irinotecan Hydrochloride for the Treatment of Advanced Alpha-fetoprotein-producing Gastric Cancer (AFPGC)

Iparomlimab and Tuvonralimab Injection Combined With Apatinib and Irinotecan Hydrochloride for the Treatment of Advanced Alpha-fetoprotein-producing Gastric Cancer (AFPGC) That Progresses From First-line PD-1 Combined Chemotherapy, A Prospective, Single-arm, Phase II Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm study aimed at evaluating the efficacy and safety of Iparomlimab and Tuvonralimab Injection combined with apatinib and irinotecan hydrochloride in the treatment of advanced alpha-fetoprotein gastric cancer (AFPGC) that progresses from first-line PD-1 combined with chemotherapy. The study enrolled patients with advanced gastric cancer and gastroesophageal junction cancer whose serum alpha-fetoprotein was greater than 20.0 ng/mL at the initial diagnosis and progressed after first-line PD-1 combined chemotherapy in a single center of the Fourth Hospital of Hebei Medical University. All patients underwent gastroscopy and were pathologically confirmed as Her-2 negative gastric adenocarcinoma, and had received PD-1 inhibitor treatment as the first-line treatment. Staged examinations include enhanced CT of the abdominal and pelvic cavities, plain CT scan of the chest, and color Doppler ultrasound of superficial lymph nodes. The enrolled patients received apalolitovolrelimab 5.0mg/kg, Q3W, d1; Apatinib mesylate, 0.25g, once daily; Irinotecan hydrochloride, 200mg/m², Q3W, d1. Combination therapy until the patient's disease progresses, or intolerable toxic and side effects occur, or until death or withdrawal of informed consent, or up to two years. The primary endpoint of the study was to assess the objective response rate (ORR) of combination therapy. Secondary endpoints included progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and the incidence of adverse events, etc

Conditions

• AFP Gastric or Gastroesophageal Junction Adenocarcinoma
• PD-1/CTLA-4
• AFPGC
• Immunotherapy

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab Injection (QL1706)	1. Iparomlimab and Tuvonralimab Injection， 5.0mg/kg, Q3W, D1; 2. Apatinib, 0.25g, once daily, orally; Irinotecan, 200mg/m², Q3W, D1; Combination therapy until the patient's disease progresses, or intolerable toxic and side effects occur, or until death or withdrawal of informed consent, or up to two years.

Timeline

• Start date: 2025-09-28
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2025-12-17
• Last updated: 2025-12-17

Locations

1 site across 1 country: China