Advanced Intrahepatic CholangiocarcinomaPhase 2ITUSNCT07152769
Iparomlimab and Tuvonralimab Combined With GC in Advanced ICC
A Phase 2 study testing Iparomlimab and Tuvonralimab + GC and Sintilimab + GC in people with Advanced Intrahepatic Cholangiocarcinoma, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Intrahepatic Cholangiocarcinoma
- What is being tested?
- Iparomlimab and Tuvonralimab + GC and Sintilimab + GC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2025to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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).
Who cannot join
- 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).
Show all 16Show fewer
- 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.
- Any medical condition (including psychiatric or substance abuse disorders), prior/concomitant treatment, or clinically significant laboratory abnormality that, in the investigator's opinion, would:Adversely affect trial data integrity, Limit the subject's ability to complete the study, Or pose undue risk to the subject.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200062
Lu Wang, M.D., +86-18121299357, w.lr@hotmail.com
About this study
Official title: Iparomlimab and Tuvonralimab Combined With Gemcitabine and Cisplatin (GC) Versus Sintilimab Combined With GC as First-Line Treatment for Advanced Intrahepatic Cholangiocarcinoma: A Single-Center, Open-Label, Randomized Controlled Phase II Study
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.
Read the detailed description
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.
The primary endpoint is investigator-assessed 6-month Progression-Free Survival Rate . Secondary endpoints include ORR, DCR, DoR, TTR, PFS, OS, AE.
This study plans to enroll 104 patients with advanced ICC. These patients are assigned in a 1:1 ratio to the Iparomlimab and Tuvonralimab Combined With GC group (experimental group) and Sintilimab Combined With GC group (control group).
- Conditions
- Advanced Intrahepatic Cholangiocarcinoma
- Being tested
- Iparomlimab and Tuvonralimab + GC, Sintilimab + GC
- Keywords
- ICC, Iparomlimab and Tuvonralimab, Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab + GCDrug
Iparomlimab and Tuvonralimab: 5mg/kg, iv, q3w; Gemcitabine: 1000 mg/m2，iv，d1、d8，q3w; Cisplatin: 25 mg/m2，iv，d1、d8，q3w
Sintilimab + GCDrug
Sintilimab: 5mg/kg, iv, q3w; Gemcitabine: 1000 mg/m2，iv，d1、d8，q3w; Cisplatin: 25 mg/m2，iv，d1、d8，q3w.
| Study group | Role | What they receive |
|---|---|---|
| Iparomlimab and Tuvonralimab + GC | Experimental | Iparomlimab and Tuvonralimab combined with Gemcitabine and Cisplatin Receives: Drug: Iparomlimab and Tuvonralimab + GC |
| Sintilimab + GC | Active comparator | Sintilimab cimbined with Gemcitabine and Cisplatin Receives: Drug: Sintilimab + GC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (7)
Progression-Free Survival (PFS)
Defined as the time from randomization to the first documented radiological disease progression or death (whichever occurs first).
Measured: up to approximately 2 years.
Objective Response Rate (ORR)
Defined as the proportion of subjects achieving a Complete Response (CR) or Partial Response (PR) among all subjects.
Measured: up to approximately 2 years.
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.
Measured: up to approximately 2 years.
Duration of Response (DOR)
Defined as the time from the first documented response (CR or PR) to disease progression or death (whichever occurs first).
Measured: up to approximately 2 years.
Time to Response (TTR)
Defined as the time from randomization to the first documented Complete Response (CR) or Partial Response (PR).
Measured: up to approximately 2 years.
Overall Survival (OS)
Defined as the time from randomization to death from any cause.
Measured: up to approximately 2 years.
Adverse Events
AE assessed by NCI-CTCAE v5.0.
Measured: up to approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start15 Oct 2025 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Wang, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152769
- Sponsor's protocol ID
- 2507325-6
- Acronym
- ITUS
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iparomlimab and Tuvonralimab Combined With Gemcitabine and Cisplatin (GC) Versus Sintilimab Combined With GC as First-Line Treatment for Advanced Intrahepatic Cholangiocarcinoma: A Single-Center, Open-Label, Randomized Controlled Phase II Study
- ClinicalTrials.gov ID
- NCT07152769
- Acronym / sponsor ID
- ITUS / 2507325-6
- Conditions
- Advanced Intrahepatic Cholangiocarcinoma
- Keywords
- ICC, Iparomlimab and Tuvonralimab, Sintilimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The primary endpoint is investigator-assessed 6-month Progression-Free Survival Rate . Secondary endpoints include ORR, DCR, DoR, TTR, PFS, OS, AE.
This study plans to enroll 104 patients with advanced ICC. These patients are assigned in a 1:1 ratio to the Iparomlimab and Tuvonralimab Combined With GC group (experimental group) and Sintilimab Combined With GC group (control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iparomlimab and Tuvonralimab + GC | Experimental | Drug: Iparomlimab and Tuvonralimab + GCIparomlimab and Tuvonralimab combined with Gemcitabine and Cisplatin |
| Sintilimab + GC | Active comparator | Drug: Sintilimab + GCSintilimab cimbined with Gemcitabine and Cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iparomlimab and Tuvonralimab + GCIparomlimab and Tuvonralimab: 5mg/kg, iv, q3w; Gemcitabine: 1000 mg/m2，iv，d1、d8，q3w; Cisplatin: 25 mg/m2，iv，d1、d8，q3w | Drug | Iparomlimab and Tuvonralimab + GC |
| Sintilimab + GCSintilimab: 5mg/kg, iv, q3w; Gemcitabine: 1000 mg/m2，iv，d1、d8，q3w; Cisplatin: 25 mg/m2，iv，d1、d8，q3w. | Drug | Sintilimab + GC |
Primary outcome
6-month progression-free survival
Time frame: 6 months
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.
7 secondary outcomes
Progression-Free Survival (PFS)
Time frame: up to approximately 2 years.
Objective Response Rate (ORR)
Time frame: up to approximately 2 years.
Disease Control Rate (DCR)
Time frame: up to approximately 2 years.
Duration of Response (DOR)
Time frame: up to approximately 2 years.
Time to Response (TTR)
Time frame: up to approximately 2 years.
Overall Survival (OS)
Time frame: up to approximately 2 years.
Adverse Events
Time frame: up to approximately 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
Related trials for Advanced Intrahepatic Cholangiocarcinoma
RecruitingPhase 3
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Biliary Tract Cancer
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy
Active, not recruitingPhase 2
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma
RecruitingPhase 1/2
A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer
Active, not recruitingPhase 2
Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)
Advanced Biliary Tract Carcinoma, Advanced Gallbladder Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab and Tuvonralimab + GC and Sintilimab + GC in people with Advanced Intrahepatic Cholangiocarcinoma, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lu Wang, M.D. (86-18121299357, w.lr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month progression-free survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.