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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Iparomlimab and Tuvonralimab + GC
DrugIparomlimab and Tuvonralimab: 5mg/kg, iv, q3w; Gemcitabine: 1000 mg/m2，iv，d1、d8，q3w; Cisplatin: 25 mg/m2，iv，d1、d8，q3w
Sintilimab + GC
DrugSintilimab: 5mg/kg, iv, q3w; Gemcitabine: 1000 mg/m2，iv，d1、d8，q3w; Cisplatin: 25 mg/m2，iv，d1、d8，q3w.
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Iparomlimab and Tuvonralimab + GCExperimental treatment 1 intervention
Group B: Sintilimab + GCActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
6-month progression-free survival
Defined as the proportion of subjects who remain free of disease progression or death within 6 months from the start of the first study treatment.
Time frame
6 monthsSecondary outcomes
1
Progression-Free Survival (PFS)
Defined as the time from randomization to the first documented radiological disease progression or death (whichever occurs first).
Time frame
up to approximately 2 years.2
Objective Response Rate (ORR)
Defined as the proportion of subjects achieving a Complete Response (CR) or Partial Response (PR) among all subjects.
Time frame
up to approximately 2 years.3
Disease Control Rate (DCR)
Defined as the proportion of subjects achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) among all subjects.
Time frame
up to approximately 2 years.4
Duration of Response (DOR)
Defined as the time from the first documented response (CR or PR) to disease progression or death (whichever occurs first).
Time frame
up to approximately 2 years.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: