Actively Recruiting
A Single-arm Phase II Clinical Study of the Efficacy and Safety of Camrelizumab Combined With GEMOX for Unresectable GBCs
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-05-21
37
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study was to evaluate the efficacy and safety of Camrelizumab combined with gemcitabine and oxaliplatin (GEMOX) for unresectable gallbladder cancer. Patients with unresectable gallbladder cancer were enrolled to receive gemcitabine 1000mg/m2 D1+oxaliplatin 100mg/m2, D1+Camrelizumab 200mg, D1, in 21-day cycles for 6-8 cycles, with serum tumour markers assessed at each course and abdominal CTA performed every two courses, until tumour progression occurs.The primary indicators of this study are radical tumor resection rate; secondary indicators are disease control rate, objective response rate,progression-free survival and overall survival; safety indicators: incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to NCI-CTCAEv5.0 criteria. 37 patients are expected to be recruited for this study.
CONDITIONS
Official Title
A Single-arm Phase II Clinical Study of the Efficacy and Safety of Camrelizumab Combined With GEMOX for Unresectable GBCs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18-75 years
- Diagnosed with unresectable gallbladder cancer confirmed by biopsy or tumor cells in bile
- No prior chemotherapy or immunotherapy treatment
- ECOG performance status score of 0-1 within 1 week before enrollment
- Expected survival longer than 3 months
- Adequate organ function including specific blood counts, liver, thyroid, and kidney function within defined limits
- Female participants of childbearing potential must have a negative pregnancy test within 14 days before treatment and agree to use reliable contraception during the study and 60 days after last dose
- Male participants with partners of childbearing potential must agree to use reliable contraception during the study and for 120 days after last dose
- Able and willing to voluntarily sign informed consent and comply with follow-up
You will not qualify if you...
- History or presence of other malignant tumors, except treated non-melanoma skin cancer, cervical carcinoma in situ, or thyroid papillary carcinoma
- Prior use of gemcitabine-based chemotherapy or PD-1/PD-L1 antibody treatment within 6 months
- Severe heart, lung, or kidney dysfunction
- Uncontrolled hypertension with systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg
- Abnormal blood clotting, bleeding tendencies, or current thrombolytic or anticoagulant therapy
- Active hepatitis B or C infection with viral loads above specified limits
- History of esophageal or gastric varices with bleeding symptoms within 3 months before enrollment
- Active infections requiring systemic treatment or untreated active tuberculosis
- HIV positive status
- History of substance abuse including psychotropic drugs or alcohol
- Known severe allergies to monoclonal antibodies, platinum drugs, or gemcitabine
- Other serious medical, psychiatric, or social conditions that may affect safety or study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510288
Actively Recruiting
Research Team
Z
Zhang Rui, PhD
CONTACT
Y
Ye Yanfang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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