Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07267078

Tuvonralimab and Iparomlimab Based Regimens for the Neoadjuvant Treatment of Biliary Tract Cancer

Led by Peking Union Medical College Hospital · Updated on 2025-12-05

45

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if Tuvonralimab/Iparomlimab-based neoadjuvant regimens can improve surgical and pathological outcomes in adults (≥18 years) with resectable or borderline-resectable biliary tract cancer (intrahepatic/extrahepatic cholangiocarcinoma or gallbladder cancer), ECOG 0-1, and no prior neoadjuvant therapy. The main questions it aims to answer are: 1. Does the regimen increase the R0 resection rate (negative margins)? 2. Does it raise major or pathologic complete response rates (MPR/pCR) and improve event-free survival (EFS) without increasing perioperative complications? Researchers will compare Tuvonralimab/Iparomlimab-based therapy + GEMOX chemotherapy to surgery to see if immunotherapy leads to higher R0 resection, deeper pathologic response, and better EFS/PFS/OS with acceptable safety. Participants will: Undergo baseline assessments: imaging (contrast-enhanced CT/MRI ± PET), labs, histology, and optional biomarker sampling. Receive neoadjuvant therapy: 2-4 cycles (\\\~6-12 weeks) of a Tuvonralimab/Iparomlimab-based regimen per protocol. Have restaging by RECIST 1.1; eligible participants proceed to curative-intent surgery with central review of margins and tumor regression grading (TRG/MPR/pCR). Receive protocol-directed postoperative management and safety monitoring (CTCAE v5.0) and be followed every 8-12 weeks for EFS, PFS, OS, conversion-to-resection rate, nodal down-staging, perioperative complications, length of stay, and any surgery delays.

CONDITIONS

Official Title

Tuvonralimab and Iparomlimab Based Regimens for the Neoadjuvant Treatment of Biliary Tract Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects voluntarily consented and can comply with follow-up
  • Age 18 to 75 years, any gender
  • Diagnosed with bile duct cancer by histology or imaging with borderline resectability
  • At least one measurable lesion per RECIST 1.1 criteria (≥10mm CT diameter or ≥15mm lymph node short diameter)
  • No prior systemic treatment
  • Locally advanced disease without distant metastasis, with potential for R0 resection
  • One of these vascular or bile duct involvement situations: affected main portal vein or hepatic artery segment with possible reconstruction; tumor involving bile duct beyond one secondary branch but sparing primary opposite branch; suspected regional lymph node metastasis without distant nodes or peritoneal implants
  • ECOG score 0-1 within one week before enrollment
  • Adequate hematology and organ function per lab tests within 14 days prior to treatment
  • Fertile women agree to abstain or use effective contraception during and 6 months after treatment
  • Men agree to abstain or use contraception and not donate sperm
Not Eligible

You will not qualify if you...

  • Prior systemic treatment
  • ECOG score greater than 1
  • Confirmed distant liver metastasis
  • Pregnant or breastfeeding women
  • Allergy to PD-1 or CTLA-4 monoclonal antibodies or their components
  • Major surgery within 4 weeks before first drug dose or unhealed surgical wounds
  • Significant cardiovascular or cerebrovascular disease within 6 months
  • Impaired liver or kidney function beyond specified thresholds
  • Persistent infection grade 2 or higher
  • History of thromboembolic events within 6 months
  • Uncontrolled hypertension
  • Active or recent autoimmune diseases requiring immunosuppression
  • Known active CNS metastasis or cancerous meningitis
  • Prior organ or bone marrow transplant
  • Active tuberculosis
  • Recent gastrointestinal bleeding or fistula
  • HIV infection
  • Active hepatitis B or C without adequate treatment
  • Severe non-healing wounds, ulcers, or fractures
  • Drug abuse or medical/social conditions affecting safety or compliance
  • Unresolved toxicities above grade 1 from prior treatments
  • Severe lung function impairment or related lung diseases
  • Recent use of potent CYP3A4 inhibitors or inducers
  • Other untreated malignant tumors within past 5 years except certain treated cancers
  • Investigator determination of unsuitability
  • Concurrent participation in another clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here