Iparomlimab and Tuvonralimab Injection Combined With GemOX and Lenvatinib as Conversion Therapy for Initially Potentially Resectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer

NCT07263360 | Not Yet Recruiting Phase 2

• 1 other identifier: E20251152
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) combined with GemOX and lenvatinib as conversion therapy for Initially Potentially Resectable intrahepatic cholangiocarcinoma and gallbladder cancer.

Conditions

BTC

Keywords

lparomlimab and Tuvonralimab injection; GemOX; Lenvatinib

Outcome Measures

Primary Outcomes (1)

• R0 Resection Rate

  up to 12 month

Secondary Outcomes (6)

• Conversion Rate

  up to 12 month

• Objective response rate

  up to 12 month

• Progression-Free Survival

  up to 12 month

• pathological Complete Response

  up to 12 month

• Overall survival

  up to 36 month

Study Arms (1)

Iparomlimab and Tuvonralimab Injection combined with GemOX and lenvatinib

EXPERIMENTAL

Iparomlimab and Tuvonralimab Injection combined with GemOX and lenvatinib

Drug: Iparomlimab and Tuvonralimab Injection combined with GemOX and lenvatinib

Interventions

Iparomlimab and Tuvonralimab Injection combined with GemOX and lenvatinib DRUG

Iparomlimab and Tuvonralimab Injection:5 mg/kg, intravenous infusion on Day 1 of each 3-week cycle (q3w); for 4 to 6 cycles. Lenvatinib: 8-12 mg, orally once daily (qd). The dose is determined by body weight:8 mg po qd for body weight \< 60 kg;12 mg po qd for body weight ≥ 60 kg GemOX Regimen: Oxaliplatin: 85 mg/m², intravenous infusion on Day 1 of each 3-week cycle (q3w); for a maximum of 6 cycles. Gemcitabine: 1000 mg/m², intravenous infusion on Day 1 and Day 8 of each 3-week cycle (q3w); for a maximum of 6 cycles. Postoperative Treatment for Patients with Successful Conversion: Iparomlimab and Tuvonralimab Injection: 5 mg/kg, intravenous infusion on Day 1 of each 3-week cycle (q3w); for 8 cycles. For Patients without Successful Conversion: Subsequent treatment regimens will be determined by the investigator.

Iparomlimab and Tuvonralimab Injection combined with GemOX and lenvatinib

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years, male or female.
• Histologically or cytologically confirmed diagnosis of locally advanced or potentially resectable intrahepatic cholangiocarcinoma or gallbladder cancer, defined as T2b-T4 or N1 M0 according to the AJCC 8th edition.
• Expected life expectancy ≥ 12 weeks.
• No prior systemic treatment for biliary tract cancer before the first dose of study medication.
• At least one measurable lesion as defined by RECIST 1.1 criteria.
• ECOG Performance Status of 0 or 1.
• Adequate organ function, without severe dysfunction of the hematologic, cardiac, pulmonary, hepatic, renal, bone marrow, or immune systems.
• Laboratory tests meeting the following requirements: Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days before enrollment and voluntarily use adequate contraception during the observation period and for 8 weeks after the last dose of the study drug. For men, they must be surgically sterile or agree to use adequate contraception during the observation period and for 8 weeks after the last dose of the study drug.
• Patient voluntarily participates and provides written informed consent.
• Good compliance is anticipated, allowing for efficacy and adverse event follow-up per the protocol.

You may not qualify if:

• The subject has received any prior antitumor therapy or any investigational anticancer agents.
• Presence of any active autoimmune disease or a history of autoimmune diseases (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism \[may be enrolled if stable on hormone replacement therapy\]). Patients with childhood asthma that has completely resolved in adulthood without any intervention, or vitiligo, may be enrolled. Patients requiring medical intervention with bronchodilators are not eligible.
• Known congenital or acquired immunodeficiency, such as Human Immunodeficiency Virus (HIV) infection.
• Uncontrolled cardiac clinical symptoms or diseases, e.g., NYHA Class II or above heart failure, unstable angina, myocardial infarction within 1 year, or patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
• Severe concurrent infection within 4 weeks prior to the first dose (e.g., requiring intravenous antibiotics, antifungals, or antivirals), or unexplained fever \>38.5°C during screening/prior to the first dose.
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Administration of a live attenuated vaccine within 4 weeks prior to the first dose or planned administration during the study period.
• History of or concurrent other malignant tumors within the past 5 years (except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, and ovarian cancer).
• Gastrointestinal bleeding event or active hemoptysis within 28 days prior to the first dose.
• Gastric or esophageal varices requiring treatment.
• Active malignant tumors within 36 months prior to enrollment.
• Known allergy to any of the investigational drug components.
• Poorly controlled psychiatric disorder.
• Presence of superior mesenteric vein tumor thrombus, metastasis to group 16 lymph nodes, or distant metastasis to other organs / biological factors: peritoneal metastasis, direct invasion to adjacent organs, etc. / involvement of organs (pancreas, stomach, duodenum, colon) that cannot be resected en bloc.
• Any other condition deemed by the investigator as unsuitable for enrollment. This includes, but is not limited to, pre-existing central nervous system metastases, severe laboratory abnormalities, or familial/social factors that could compromise the subject's safety, or data/sample collection.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Interventions

lenvatinib

Central Study Contacts

Wei Zhang

CONTACT

+86 18622025401; zhangweitjch@163.com

Wen X Liu

CONTACT

18515456035; liuwenxiao2016@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)