Status:
RECRUITING
Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Cervical Cancer
Induction Chemotherapy
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
To explore the efficacy of incorporating neoadjuvant immunotherapy into neoadjuvant chemotherapy in locally advanced cervical cancer patients with high risk of recurrence.
Detailed Description
For locally advanced cervical cancer patients undergoing definitive chemoradiotherapy, distant metastasis has become a major concern. In this study, investigators selected a subgroup of patients with ...
Eligibility Criteria
Inclusion
- Untreated locally advanced cervical cancer patients with clear pathological diagnosis
- 2019 FIGO stage IIIB-IVA. For patients with stage IIIC disease, the short diameter of their metastatic lymph nodes should ≥1.5cm
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Life expectancy \> 6 months
- Able to tolerate concurrent chemoradiotherapy assessed by researches
- No obvious active bleeding;
- Adequate hematological, renal and hepatic functions:
- No concomitant malignancies
- Female subjects of childbearing potential should have a negative pregnancy test and must take effective and reliable contraceptive measures during the clinical trial period;
- Voluntarily-signed informed consent.
Exclusion
- Concomitant other malignancies;
- Patients with metastatic or recurrent disease;
- Patients received any form of treatment before enrollment;
- Severe concomitant chronic diseases (diabetes, hypertension, etc.) or acute infections;
- Impaired hematological, renal or hepatic functions:
- Hemoglobin \< 9.0 g/dl
- Neutrophils \< 2000 cells/μl; Leukocytes \< 4 × 109/L
- Platelets \> 100 × 109/L
- Serum ALT/AST \> 2.5×UNL
- Serum Total bilirubin \> 1.5× UNL
- g. Serum urea nitrogen (BUN) \> 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) \> 1.5 × upper normal limit (UNL)
- Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency or severe heart valve disease;
- Patients with uncontrolled mental diseases;
- Pregnant or lactating woman;
- Participating in other clinical trials;
- Anyone considered not suitable for enrollment by principal investigator;
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06093438
Start Date
November 1 2023
End Date
July 1 2026
Last Update
March 11 2025
Active Locations (1)
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1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060