Actively Recruiting
Iparomlimab and Tuvonralimab Combined With Apatinib and Irinotecan Hydrochloride for the Treatment of Advanced Alpha-fetoprotein-producing Gastric Cancer (AFPGC)
Led by Hebei Medical University Fourth Hospital · Updated on 2025-12-17
39
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Iparomlimab and Tuvonralimab Combined With Apatinib and Irinotecan Hydrochloride for the Treatment of Advanced Alpha-fetoprotein-producing Gastric Cancer (AFPGC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma diagnosed by pathology or cytology
- Serum alpha-fetoprotein level greater than 20.0 ng/mL at diagnosis
- At least one measurable lesion per RECIST v1.1 criteria
- Disease progression after first-line PD-1 combined chemotherapy or relapse within 6 months after adjuvant/neoadjuvant chemotherapy combined with PD-1 inhibitors
- ECOG performance status 0-1
- Expected survival time of at least 12 weeks
- Vital organ function within 7 days before enrollment meeting specified blood count and biochemical criteria without recent use of blood components or growth factors
- Women of childbearing potential must use effective contraception
- Good compliance and willingness to cooperate with follow-up visits
You will not qualify if you...
- Inability to comply with study procedures
- HER2-positive gastric cancer
- Gastric cancer of squamous cell carcinoma, undifferentiated carcinoma, or mixed tissue types other than adenocarcinoma
- Conditions affecting drug absorption
- Severe cardiovascular diseases such as uncontrollable heart failure, coronary heart disease, arrhythmia, or uncontrolled hypertension
- Active brain metastases, except certain stable or treated cases
- Allergy to study drugs
- Prior treatment with immune checkpoint inhibitors other than anti-PD-1/PD-L1 antibodies or drugs affecting T-cell pathways
- Significant bleeding or thrombotic events within specified recent timeframes
- Uncontrolled active infections including acute pneumonia or active hepatitis B or C
- History of primary immunodeficiency or active pulmonary tuberculosis
- History of organ or stem cell transplantation
- HIV infection
- Significant malnutrition within recent months unless corrected
- History of other primary malignancies except those in complete remission or adequately treated non-melanoma skin cancer or carcinoma in situ
- Pregnancy or breastfeeding
- Any concomitant disease or condition deemed unsafe or interfering with study completion by the investigator
- Investigator's judgment of unsuitability for study inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
Research Team
F
Fengbin Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here