Iparomlimab and Tuvonralimab Combined With GC in Advanced ICC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University
About this trial
This study is a randomized, controlled, open-label, single center clinical study. This study is designed to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Combined With GC versus Sintilimab Combined With GC as first-line therapy in advanced ICC.
Eligibility criteria
Qualifiers
Signed written informed consent obtained prior to any trial-related procedures.
Male or female， ≥18 years and ≤75 years.
Histologically confirmed unresectable advanced or metastatic intrahepatic cholangiocarcinoma (ICC). Patients who developed recurrence more than 6 months after radical surgery are eligible. If adjuvant therapy (chemotherapy and/or radiotherapy) was received, recurrence must have occurred more than 6 months after completion of adjuvant therapy.
At least one measurable tumor lesion according to RECIST version 1.1 criteria.
Disqualifiers
Previous treatment with agents targeting stimulatory or co-inhibitory T-cell receptors other than PD-1/PD-L1 (e.g., CTLA-4, OX-40, CD137).
Systemic administration of Chinese herbal medicines with claimed anti-tumor indications or immunomodulatory agents (including thymosin, interferon, interleukin; excluding local use for pleural effusion control) within 2 weeks prior to the first dose.
History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic therapy. Known history of primary immunodeficiency.
Current systemic corticosteroid therapy (>10 mg/day prednisone equivalent) or any other form of immunosuppressive therapy within 4 weeks prior to the first study dose.
Trial design
Treatments tested in this trial
- Iparomlimab and Tuvonralimab + GC
- Sintilimab + GC
Treatment groups
104 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov