Iparomlimab and Tuvonralimab Combined With GC in Advanced ICC

NCT07152769 | Not Yet Recruiting Phase 2

• 1 other identifier: 2507325-6
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Intrahepatic Cholangiocarcinoma

Keywords

ICC; Iparomlimab and Tuvonralimab; Sintilimab

Outcome Measures

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.

  6 months

Secondary Outcomes (7)

• Progression-Free Survival (PFS)

  up to approximately 2 years.

• Objective Response Rate (ORR)

  up to approximately 2 years.

• Disease Control Rate (DCR)

  up to approximately 2 years.

• Duration of Response (DOR)

  up to approximately 2 years.

• Time to Response (TTR)

  up to approximately 2 years.

Study Arms (2)

Iparomlimab and Tuvonralimab + GC

EXPERIMENTAL

Iparomlimab and Tuvonralimab combined with Gemcitabine and Cisplatin

Drug: Iparomlimab and Tuvonralimab + GC

Sintilimab + GC

ACTIVE COMPARATOR

Sintilimab cimbined with Gemcitabine and Cisplatin

Drug: Sintilimab + GC

Interventions

Iparomlimab and Tuvonralimab + GC DRUG

Iparomlimab and Tuvonralimab: 5mg/kg, iv, q3w; Gemcitabine: 1000 mg/m2，iv，d1、d8，q3w; Cisplatin: 25 mg/m2，iv，d1、d8，q3w

Iparomlimab and Tuvonralimab + GC

Sintilimab + GC DRUG

Sintilimab: 5mg/kg, iv, q3w; Gemcitabine: 1000 mg/m2，iv，d1、d8，q3w; Cisplatin: 25 mg/m2，iv，d1、d8，q3w.

Sintilimab + GC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• No prior systemic therapy (chemotherapy, targeted therapy, or immunotherapy) for advanced/metastatic disease.
• Life expectancy of at least 12 weeks.
• ECOG Performance Status (PS) of 0 or 1.
• Subjects must meet the following laboratory parameters: 1)Absolute Neutrophil Count (ANC): ≥ 1.5 × 10⁹/L (without granulocyte colony-stimulating factor support within the last 14 days). 2)Platelets: ≥ 100 × 10⁹/L (without transfusion within the last 14 days). 3)Hemoglobin: \> 9 g/dL (without transfusion or erythropoietin use within the last 14 days). 4)Total Bilirubin: ≤ 1.5 × Upper Limit of Normal (ULN). 5)Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT): ≤ 2.5 × ULN. 6)Creatinine Clearance: Calculated creatinine clearance (using the Cockcroft-Gault formula) ≥ 60 mL/min.
• The subject is willing and able to comply with the protocol during the study period, including receiving treatment, adhering to contraceptive measures, and attending scheduled visits and examinations (including follow-up).

You may not qualify if:

• 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.
• Subjects with only positive autoimmune antibodies must be evaluated by the Investigator to confirm the absence of an autoimmune disease.
• 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.
• Presence of clinically uncontrolled pleural effusion or ascites (subjects who do not require drainage or whose effusion shows no significant increase for ≥3 days after stopping drainage may be enrolled).
• Known history of allogeneic organ transplantation (excluding corneal transplants) or allogeneic hematopoietic stem cell transplantation.
• Known hypersensitivity to the active pharmaceutical ingredients or excipients of the investigational products used in this study.
• Failure to recover adequately (i.e., to ≤ Grade 1 or baseline, excluding alopecia or fatigue) from toxicities and/or complications of any prior interventions before initiation of study treatment.
• Known history of Human Immunodeficiency Virus (HIV) infection (i.e., HIV 1/2 antibodies positive).
• Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA exceeding the upper limit of normal (ULN) at the central laboratory of the participating site).
• Active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA levels above the lower limit of detection).
• Administration of a live attenuated vaccine within 4 weeks prior to the first dose.
• Positive pregnancy test within 7 days prior to the first dose or currently breastfeeding, for women of childbearing potential.
• Presence of any severe and/or uncontrolled systemic disease/disorder.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200062, China

Location

MeSH Terms

Interventions

sintilimab

Central Study Contacts

Lu Wang, M.D.

CONTACT

86-18121299357; w.lr@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

CN (1)