Cholangiocarcinoma: thirty-one-year experience with 564 patients at a single institution.
Michelle L DeOliveira, Steven C Cunningham, John L Cameron...
https://pubmed.ncbi.nlm.nih.gov/17457168Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID05430698
PD-1 Antibody Plus Gemcitabine and Oxaliplatin (GEMOX) as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma Patients With Positively Metastatic Lymph Nodes: A Single Arm Phase II Trial
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-02-09
62
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining a PD-1 antibody with GEMOX chemotherapy as a postoperative treatment for patients with perihilar cholangiocarcinoma who have cancer spread to their lymph nodes. This exploratory, open-label study seeks to find better options for patients whose prognosis is poorer due to lymph node metastasis after surgery. Participants receive PD-1 antibody infusions and GEMOX chemotherapy, which includes gemcitabine and oxaliplatin. Treatments are given intravenously in cycles lasting three weeks each, with a total of 6 to 8 cycles planned. This combined therapy is given after surgery to assess its potential as an adjuvant treatment. During the study, participants will be closely monitored for disease recurrence and survival, with the main outcome being the relapse-free survival rate at 12 months. Additional assessments include overall survival rates, adverse events, and organ function tests. The study will last several years, including follow-up for up to 60 months to gather long-term data on treatment effects and safety.
CONDITIONS
Brief Title
PD-1 Antibody Plus GEMOX as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age between 18 and 75 years, any gender
- ECOG performance status score of 0 or 1
- Child-Pugh score A phase
- Perihilar cholangiocarcinoma with negative surgical margins and positively metastatic lymph nodes confirmed by histopathology
- No systemic treatment received within the past 6 months
- Adequate organ function including neutrophils 2 1.5 x 10^9/L, platelets 2 100 x 10^9/L, hemoglobin 2 9 g/dl, serum albumin 2 3 g/dl
- Thyroid function within normal limits or TSH no more than twice the upper limit
- Bilirubin no more than 1.5 times upper limit of normal; ALT and AST no more than 3 times upper limit
- Serum creatinine no more than 1.5 times upper limit and creatinine clearance 2 60 ml/min
- At least one measurable lesion per RECIST1.1
- Women not pregnant or breastfeeding and using contraception during treatment and 12 months after
You will not qualify if you...
- Unresectable perihilar cholangiocarcinoma or recurrence/metastasis diagnosed after surgery
- Current or past other malignant tumors except fully treated non-melanoma skin cancer, cervical carcinoma in situ, or thyroid papillary carcinoma
- Use of gemcitabine-based chemotherapy or PD-1/PD-L1 monoclonal antibodies within 6 months
- Severe heart, lung, or kidney dysfunction
- Poorly controlled high blood pressure (systolic 2 140 mmHg or diastolic 2 90 mmHg)
- Abnormal blood clotting, bleeding tendency, or current anticoagulation therapy
- Active viral infections with high levels of HBV or HCV
- History of recent or active tuberculosis
- HIV positive
- History of substance abuse including psychotropic drugs or alcohol
- Severe allergies to monoclonal antibodies, platinum drugs, or gemcitabine
- Other serious medical, psychiatric, laboratory, family, or social issues that may affect safety or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 to 8 courses of treatment, each course lasting 3 weeks
Participants receive PD-1 antibody plus GEMOX chemotherapy as postoperative adjuvant therapy following surgery for perihilar cholangiocarcinoma with lymph node metastasis.
Visits on Day 1 and Day 8 of each 3-week course, for up to 8 courses
Follow-up
Duration - Up to 60 months
Participants are followed to monitor relapse-free survival and overall survival after completing adjuvant therapy.
Visits scheduled periodically over 60 months after treatment completion
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
Y
Yanfang Ye
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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