Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer Patients With High Risk of Recurrence: A Prospective, Single-Arm, Phase II Trial
Overview
- Phase
- Phase 1
- Intervention
- Toripalimab
- Conditions
- Cervical Cancer
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Overall response rate
- Status
- Recruiting
- Last Updated
- last year
Overview
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 theoretically higher risk of distant metastasis and intensified their systematic treatment by incorporating PD-L1 inhibitors into neoadjuvant chemotherapy, in order to reduce their risk of distant metastasis and achieve good disease-free survival.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Induction immunotherapy and chemotherapy
Patients enrolled in this arm would receive neoadjuvant immunotherapy and chemotherapy before definitive chemoradiation
Intervention: Toripalimab
Outcomes
Primary Outcomes
Overall response rate
Time Frame: 1 year
The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1
Volume changes of core radiation targets and irradiated normal tissues after induction treatment
Time Frame: 5-year
Volume change of PTV, PGTVnd, Bladder V45, V50, Dmax, Dmean, Rectum V45, V50, Dmax, Dmean, Bowel bag V45, V50
Secondary Outcomes
- Distant metastasis-free survival(1-year, 2-year)
- Incidence of treatment-related side effects(5-year)
- Progression-free survival(1-year, 2-year)