Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

Phase 1

Recruiting

• Conditions: Cervical Cancer; Induction Chemotherapy; Immunotherapy
• Interventions: Drug: Toripalimab

• Registration Number: NCT06093438
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Study Timeline

• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-16
• Study First Posted: 2023-10-23
• Study Start: 2023-11-01
• Status Verified: 2024-09
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-11-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Induction immunotherapy and chemotherapy	Toripalimab	Patients enrolled in this arm would receive neoadjuvant immunotherapy and chemotherapy before definitive chemoradiation

Primary Outcome Measures

Name	Time	Method
Overall response rate	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	5-year	Volume change of PTV, PGTVnd, Bladder V45, V50, Dmax, Dmean, Rectum V45, V50, Dmax, Dmean, Bowel bag V45, V50

Secondary Outcome Measures

Name	Time	Method
Distant metastasis-free survival	1-year, 2-year	Time from diagnosis to distant metastasis or death due to any cause
Incidence of treatment-related side effects	5-year	Incidence of treatment-related side effects (i.e., radiation-related proctitis, cystitis, ,vaginitis, etc.)
Progression-free survival	1-year, 2-year	Time from diagnosis of disease to disease progression or death due to any cause

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute & Hospital; 🇨🇳 Tianjin, Tianjin, China