Actively Recruiting
Toripalimab Combined With Gemcitabine and Cisplatin (GemCis) as Preoperative Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-12-06
70
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was a randomized controlled trial to evaluate the efficacy and safety of toripalimab combined with GemCis (gemcitabine and cisplatin) as preoperative neoadjuvant therapy for resectable ICC at high risk of recurrence.
CONDITIONS
Official Title
Toripalimab Combined With Gemcitabine and Cisplatin (GemCis) as Preoperative Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Diagnosed with intrahepatic cholangiocarcinoma suitable for surgery
- Tumor meets at least one of the following: single tumor larger than 5 cm, single tumor with vascular invasion, up to 3 multiple tumors, tumor penetrating visceral peritoneum or invading nearby organs, or suspicious lymph node metastasis in specific zones
- No prior systemic treatment for this cancer
- ECOG performance status score of 0 or 1
- Normal function of main organs with no serious blood, heart, lung, liver, kidney, bone marrow problems or immune deficiency
- Women of childbearing age must have a negative pregnancy test within 14 days before enrollment and agree to use contraception during the study and for 8 weeks after last treatment; men must be surgically sterile or agree to use contraception during the same period
- Voluntary participation with signed informed consent
- Expected good compliance for follow-up and treatment evaluation
You will not qualify if you...
- Previous treatment with PD-1, PD-L1, PD-L2, CTLA-4 inhibitors or similar T cell receptor therapies
- Participation in other drug studies within 4 weeks before enrollment
- Active or history of autoimmune diseases such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, or thyroid disorders after hormone therapy
- Immune system defects including HIV infection
- Uncontrolled heart conditions such as heart failure NYHA II or above, unstable angina, recent myocardial infarction, or arrhythmias needing intervention
- Severe infection requiring intravenous antibiotics, antifungals, or antivirals within 4 weeks before treatment or fever over 38.5°C during screening
- History of organ or stem cell transplantation
- Receipt of live attenuated vaccine within 4 weeks before treatment or planned during study
- Other malignancies within 5 years except cured skin basal cell carcinoma, cervical carcinoma in situ, and ovarian cancer
- Allergy to any study drugs
- Pregnancy or breastfeeding, or unwillingness to use effective contraception
- Uncontrolled psychiatric disorders
- Any other condition the researcher deems unsuitable including CNS metastasis, serious lab abnormalities, or social factors affecting safety or data collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
Q
Qiang Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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