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Recruiting Phase 1, Phase 2 NCT06093438

NCT06093438 Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

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Clinical Trial Summary
NCT ID NCT06093438
Status Recruiting
Phase Phase 1, Phase 2
Sponsor Tianjin Medical University Cancer Institute and Hospital
Condition Cervical Cancer
Study Type INTERVENTIONAL
Enrollment 20 participants
Start Date 2023-11-01
Primary Completion 2025-11-01

Trial Parameters

Condition Cervical Cancer
Sponsor Tianjin Medical University Cancer Institute and Hospital
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 20
Sex FEMALE
Min Age 18 Years
Max Age 75 Years
Start Date 2023-11-01
Completion 2025-11-01
Interventions
Toripalimab

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Brief Summary

To explore the efficacy of incorporating neoadjuvant immunotherapy into neoadjuvant chemotherapy in locally advanced cervical cancer patients with high risk of recurrence.

Eligibility Criteria

Inclusion Criteria: 1. Untreated locally advanced cervical cancer patients with clear pathological diagnosis 2. 2019 FIGO stage IIIB-IVA. For patients with stage IIIC disease, the short diameter of their metastatic lymph nodes should ≥1.5cm 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 4. Life expectancy \> 6 months 5. Able to tolerate concurrent chemoradiotherapy assessed by researches 6. No obvious active bleeding; 7. Adequate hematological, renal and hepatic functions: 8. No concomitant malignancies 9. Female subjects of childbearing potential should have a negative pregnancy test and must take effective and reliable contraceptive measures during the clinical trial period; 10. Voluntarily-signed informed consent. Exclusion Criteria: 1. Concomitant other malignancies; 2. Patients with metastatic or recurrent disease; 3. Patients received any form of treatment before enrollment; 4. Severe concomitant chronic diseases (diabetes, hypertension, etc.) or acute infect

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