Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

NCT06093438 | Recruiting Phase 1

• 1 other identifier: 2020230207083952035
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervical Cancer; Induction Chemotherapy; Immunotherapy

Keywords

cervical cancer; immunotherapy; neoadjuvant chemotherapy; chemoradiation

Outcome Measures

Primary Outcomes (2)

• Overall response rate

  The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1

  1 year

• Volume changes of core radiation targets and irradiated normal tissues after induction treatment

  Volume change of PTV, PGTVnd, Bladder V45, V50, Dmax, Dmean, Rectum V45, V50, Dmax, Dmean, Bowel bag V45, V50

  5-year

Secondary Outcomes (3)

• Progression-free survival

  1-year, 2-year

• Distant metastasis-free survival

  1-year, 2-year

• Incidence of treatment-related side effects

  5-year

Study Arms (1)

Induction immunotherapy and chemotherapy

EXPERIMENTAL

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

Drug: Toripalimab

Interventions

Toripalimab 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).

Induction immunotherapy and chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Untreated locally advanced cervical cancer patients with clear pathological diagnosis
• 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.

You may not qualify if:

• 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
• g. Serum urea nitrogen (BUN) \> 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) \> 1.5 × upper normal limit (UNL)
• Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency or severe heart valve disease;
• Patients with uncontrolled mental diseases;
• Pregnant or lactating woman;
• Participating in other clinical trials;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jie Chen

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuanjie Cao

CONTACT

+86-18522123151; cyjro325@gmail.com

Chen Li

CONTACT

+86-15510932601; lichen.radonco@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 23, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2024-09

Locations

CN (1)