Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05430698

PD-1 Antibody Plus GEMOX as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-02-09

62

Participants Needed

1

Research Sites

256 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an open-label,single center,non-randomized,single arm exploratory study. The objective of this study is to evaluate the efficacy and safety of PD-1 antibody plus GEMOX as postoperative adjuvant therapy in perihilar cholangiocarcinoma with positively metastatic lymph nodes.

CONDITIONS

Official Title

PD-1 Antibody Plus GEMOX as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form
  • Age between 18 and 75 years, male or female
  • ECOG performance status score of 0 or 1
  • Child-Pugh score of A
  • Perihilar cholangiocarcinoma with negative tumor margins and positively metastatic lymph nodes confirmed by pathology
  • No systemic treatment received within the last 6 months
  • Adequate organ function including specified blood counts, thyroid function, liver function, and kidney function
  • At least one measurable lesion according to RECIST 1.1
  • For women, not pregnant or breastfeeding and use of contraception during treatment and for 12 months after treatment
Not Eligible

You will not qualify if you...

  • Unresectable perihilar cholangiocarcinoma or evidence of recurrence or metastasis after surgery
  • History or presence of other malignancies except fully treated non-melanoma skin cancer, cervical carcinoma in situ, or thyroid papillary carcinoma
  • Prior gemcitabine-based chemotherapy or PD-1/PD-L1 antibody treatment within 6 months
  • Severe heart, lung, or kidney dysfunction
  • Uncontrolled hypertension with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg
  • Abnormal blood clotting function or bleeding disorders or receiving clot prevention therapy
  • Active hepatitis B or C infection with specified viral loads
  • History of esophageal or gastric varices with recent or significant bleeding
  • Active infections requiring treatment or tuberculosis infection within the past year without proper treatment
  • Positive for HIV infection
  • History of substance abuse including psychotropic drugs, alcohol, or drugs
  • Known severe allergies to monoclonal antibodies, platinum drugs, or gemcitabine
  • Other serious medical, psychiatric, or social conditions that may affect safety or trial compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 376032

Actively Recruiting

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Research Team

R

Rui Zhang, PhD

CONTACT

Y

Yanfang Ye

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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