Actively Recruiting
Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer
Led by First Affiliated Hospital of Guangxi Medical University · Updated on 2023-09-11
112
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of tislelizumab combined with concurrent chemoradiotherapy in first-line treatment of stage IIIC2 cervical cancer.
CONDITIONS
Official Title
Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Histologically confirmed squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- Diagnosed with 2018 FIGO stage IIIC2 cervical cancer
- At least one measurable lesion based on RECIST 1.1 criteria
- Eastern Cooperative Oncology Group performance score of 0 or 1
- No evidence of metastatic disease
- Expected to live at least 6 months
- Normal organ and marrow function including hemoglobin ≥90 g/L, neutrophils ≥1.5 x10^9/L, platelets ≥80 x10^9/L, albumin ≥30 g/L, total bilirubin ≤1.5 times institutional upper limit, AST/ALT ≤2.5 times institutional upper limit, creatinine clearance ≥60 mL/min
- Menopausal patients or those of reproductive potential must use effective contraception during the study and have a negative pregnancy test; non-lactating women only
- Volunteered and signed informed consent
You will not qualify if you...
- Diagnosed with any other cancer within the past 5 years
- Known allergy to any component of the study drug
- Congenital or acquired immune deficiency such as HIV infection
- Presence of any active or suspected autoimmune disease including but not limited to interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, hypothyroidism; history of vitiligo or asthma requiring bronchodilators
- Active infection needing systemic treatment
- Prior treatment with PD-1, PD-L1, CTLA-4 antibodies, or other immunomodulatory drugs
- Unresolved grade >2 toxic reactions from previous treatments according to NCI CTCAE v5.0
- History of myocardial infarction, stroke, unstable angina, decompensated heart failure, or deep vein thrombosis
- Long-term uncured wounds or fractures; major surgery, severe trauma, fracture, or ulcer within 4 weeks
- Pregnant or lactating women
- Presence of metastatic disease
- Liver or kidney failure
- History of psychotropic drug abuse or mental disorders affecting participation
- Participation in other drug clinical trials within 4 weeks
- Other diseases or abnormal tests that interfere with anticancer therapy as judged by investigator
- Judged by investigator to not benefit from the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
Research Team
S
shanshan ma, M.D.
CONTACT
Y
yong zhang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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