NCT05511623 Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer
| NCT ID | NCT05511623 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | First Affiliated Hospital of Guangxi Medical University |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 112 participants in total. It began in 2022-09-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the efficacy and safety of tislelizumab combined with concurrent chemoradiotherapy in first-line treatment of stage IIIC2 cervical cancer.
Eligibility Criteria
Inclusion criteria: (1)18-70 years old; (2)Histologically confirmed squamous carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix; (3)Patients with 2018 FIGO stage IIIC2 cervical cancer; (4)At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1; (5)Eastern Cooperative Oncology Group score 0-1; (6)No metastatic diseases; (7)Must have an average life expectancy of 6 months; (8)Participants must have normal organ and marrow function as defined below: (hemoglobin ≥90g/L,neutrophils ≥1.5×109/L, platelets ≥80×109/L, ALB≥30g/L, Total bilirubin≤1.5 x institutional upper limit of normal, AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal, Creatinine clearance≥60 mL/min; (9)Patients with menopause, or patients of reproductive potential were required to take effective contraceptive measures for the duration of the study and had a negative pregnancy test result, non-lactating women; (10)Patients volunteered to participate in the study and sign the informed consent. Exclusion criteria: 1. Diagnosed with any other cancer within the past 5 years; 2. Known allergy to any component of the drug; 3. Congenital or acquired immune deficiency (such as HIV infection); 4. The presence of any active, known or suspected autoimmune disease (such as, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, hypothyroidism, etc.); Medical history of vitiligo; asthma which requires bronchodilators for medical intervention; 5. Active infection requiring systemic treatment; 6. Previously treatment with PD-1 and/or PD-L1, or CTLA-4 antibody, or other medications targeting immunomodulatory receptors; 7. Patients with grade\>2 unrelieved toxic reactions (based on National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0) caused by any previous treatment; 8. With a history of myocardial infarction,stroke, unstable angina, decompensated heart failure, or deep vein thrombosis; 9. Long-term uncured wounds or fractures; Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks; 10. Pregnant or lactating women; 11. With metastatic diseases; 12. Liver/renal insufficiency; 13. Those who have a history of psychotropic drug abuse and cannot get rid of it or those with mental disorders; 14. Those who have participated in clinical trials with other drugs within 4 weeks; 15. Patients with concomitant diseases or abnormal test results which interfere with the ability to receive anticancer therapy judged by the investigator; 16. Patients could not gain the maximum benefit from this study judged by the investigator.
Contact & Investigator
fang wu, M.D.
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Guangxi Medical University
Frequently Asked Questions
Who can join the NCT05511623 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05511623 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05511623 currently recruiting?
Yes, NCT05511623 is actively recruiting participants. Contact the research team at 56716690@qq.com for enrollment information.
Where is the NCT05511623 trial being conducted?
This trial is being conducted at Nanning, China.
Who is sponsoring the NCT05511623 clinical trial?
NCT05511623 is sponsored by First Affiliated Hospital of Guangxi Medical University. The principal investigator is fang wu, M.D. at First Affiliated Hospital of Guangxi Medical University. The trial plans to enroll 112 participants.
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