NCT07289997

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

Recruiting now Phase 2 Last updated 4 December 2025

What this trial tests

Phase 2 trial testing Iparomlimab and Tuvonralimab Injection (QL1706) in AFP Gastric or Gastroesophageal Junction Adenocarcinoma in 39 participants. Currently enrolling.

Timeline

28 September 2025

Primary endpoint
1 September 2027

1 September 2028

Quick facts

Lead sponsor	Hebei Medical University Fourth Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	28 September 2025
Primary completion	1 September 2027
Estimated completion	1 September 2028
Sites	1 location across China

Drugs / interventions tested

• Iparomlimab and Tuvonralimab Injection (QL1706)

Conditions studied

• AFP Gastric or Gastroesophageal Junction Adenocarcinoma — all drugs for AFP Gastric or Gastroesophageal Junction Adenocarcinoma →
• PD-1/CTLA-4 — all drugs for PD-1/CTLA-4 →
• AFPGC — all drugs for AFPGC →
• Immunotherapy — all drugs for Immunotherapy →

Sponsor

Hebei Medical University Fourth Hospital

Who can join

18 and older, any sex, with AFP Gastric or Gastroesophageal Junction Adenocarcinoma or PD-1/CTLA-4. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Objective response rate (ORR)
  Time frame: 24months
  The objective response rate (ORR), which is the proportion of patients with complete response and partial response as assessed according to the RECIST1.1 criteria

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Molecular pathogenesis and novel therapeutic avenues in alpha-fetoprotein-producing gastric cancer.
   Liu G, Zhang J, Ji F, Li Z. · · 2026 · PMID 42088224 · DOI 10.3389/fonc.2026.1814851