Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

NCT ID: NCT06093438

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-07-01

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.

Conditions

Cervical Cancer; Induction Chemotherapy; Immunotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Induction immunotherapy and chemotherapy

Patients enrolled in this arm would receive neoadjuvant immunotherapy and chemotherapy before definitive chemoradiation

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: DRUG

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).

Interventions

Toripalimab

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).

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jie Chen

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuanjie Cao

Role: CONTACT

cyjro325@gmail.com

+86-18522123151

Chen Li

Role: CONTACT

lichen.radonco@tmu.edu.cn

+86-15510932601

Other Identifiers

2020230207083952035

Identifier Type: -

Identifier Source: org_study_id