Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

Trial Title: Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

NCT ID: NCT06093438

Condition: Cervical Cancer
Induction Chemotherapy
Immunotherapy

Conditions: Official terms:
Uterine Cervical Neoplasms

Conditions: Keywords:
cervical cancer
immunotherapy
neoadjuvant chemotherapy
chemoradiation

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Toripalimab
Description: Patients enrolled in this arm would receive three cycles of induction treatment before receiving definitive chemoradiotherapy. The specific regimen is: Paclitaxel(135mg/m2,ivd, d1)+cisplatin(75mg/m2,ivd,d1-3)+Toripalimab (240mg,ivd,d1)±bevacizumab(ivd, d1)/q21d. Patients would receive pelvic MRI to evaluate the regression status of tumor after three cycles of induction treatment. Patients with satisfying tumor regression would receive definitive chemoradiotherapy afterwards. During chemoradiotherapy, patients would receive weekly cisplatin (40mg/m2) and 240mg toripalimab every three weeks. After chemoradiotherapy, patients would receive another three cycles of consolidated treatment (regimen identical to induction treatment).
Arm group label: Induction immunotherapy and chemotherapy

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.

Criteria for 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 infections; 5. Impaired hematological, renal or hepatic functions: 1. Hemoglobin < 9.0 g/dl 2. Neutrophils < 2000 cells/μl; Leukocytes < 4 × 109/L 3. Platelets > 100 × 109/L 4. Serum ALT/AST > 2.5×UNL 5. 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) 6. Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency or severe heart valve disease; 7. Patients with uncontrolled mental diseases; 8. Pregnant or lactating woman; 9. Participating in other clinical trials; 10. Anyone considered not suitable for enrollment by principal investigator;

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Tianjin Medical University Cancer Institute & Hospital

Address:
City: Tianjin
Zip: 300060
Country: China

Status: Recruiting

Start date: July 1, 2023

Completion date: July 1, 2026

Lead sponsor:
Agency: Tianjin Medical University Cancer Institute and Hospital
Agency class: Other

Source: Tianjin Medical University Cancer Institute and Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06093438