Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

• Status: Recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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;