Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06892925

QL1706 Combined With Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors

Led by Eastern Hepatobiliary Surgery Hospital · Updated on 2025-07-10

59

Participants Needed

1

Research Sites

198 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

QL1706 Combined with Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors：A Single - Arm, Open - Label, Multi - Center, Prospective Phase II Clinical Trial (Spring Study)

CONDITIONS

Official Title

QL1706 Combined With Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient voluntarily agrees to participate and signs informed consent with good compliance
  • Patient is 18 years or older, any gender
  • Histologically confirmed unresectable locally advanced or metastatic biliary tract cancer, including intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer
  • Newly diagnosed unresectable biliary tract cancer with no prior systemic therapy
  • Prior radical treatment allowed if recurrence is more than 6 months after treatment
  • At least one measurable lesion per RECIST v1.1 that can be repeatedly measured
  • ECOG Performance Status score of 0 or 1
  • Expected survival of at least 12 weeks
  • Adequate organ and bone marrow function within 14 days before treatment, meeting specified hematology and biochemistry criteria
  • HBV-infected patients with detectable HBV DNA must receive and continue antiviral therapy during and 6 months after study
  • Women of childbearing potential must have a negative pregnancy test within 7 days before first dose
  • Women of childbearing potential must use effective contraception from screening until 120 days after last dose
  • Non-sterilized male patients must use effective contraception from screening until 120 days after last dose
  • Willing and able to comply with study visits, treatment plans, and tests
Not Eligible

You will not qualify if you...

  • Rare histopathological types of cholangiocarcinoma such as ampullary cancer, small cell cancer, neuroendocrine tumors, sarcoma, and mucinous cystic tumors
  • Other malignancies within 5 years except cured basal cell carcinoma of skin or carcinoma in situ of cervix
  • History of leptomeningeal carcinoma or brain metastasis
  • Participation in another interventional clinical trial within past 3 months or concurrent enrollment in another study except observational or follow-up studies
  • Diseases disqualifying participation such as uncontrolled hypertension, active bleeding, infection, interstitial lung disease, severe gastrointestinal disease, psychiatric illness, or organ transplantation history
  • Severe cardiovascular diseases including NYHA class II or above heart failure, unstable angina, recent myocardial infarction, uncontrolled arrhythmia, cerebrovascular accident within 12 months, low ejection fraction, prolonged QTc, or poorly controlled hypertension
  • Active autoimmune disease within past 2 years or history of recurrent autoimmune disease excluding controlled thyroid disease
  • Previous immunotherapy with immune checkpoint inhibitors or agonists except therapeutic vaccines
  • Co-infection with HBV and HCV or HDV
  • Severe gastrointestinal conditions or acute exacerbations within 6 months or 1 month respectively
  • Life-threatening bleeding event within 3 months prior
  • Major surgery or severe trauma within 30 days before first dose or planned major surgery within 30 days after first dose
  • Pregnant or breastfeeding women or unwillingness to use contraception as required
  • Known allergies to study drugs or excipients
  • Other conditions deemed unsuitable by physician

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

the Third Affiliated Hospital of Naval Medical University

Shanghai, Shanghai Municipality, China, 200433/201805

Actively Recruiting

Loading map...

Research Team

X

Xiao-Feng Zhang

CONTACT

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