Neoadjuvant Chemotherapy Combined With PD-1 + Radical Radiotherapy in Locally Advanced Cervical Cancer

NCT05554276 | Recruiting Phase 2

• 1 other identifier: CSH06R101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Based on various external factors and differences in the basic characteristics of patients, in my country, it is not clear whether concurrent chemoradiotherapy can achieve optimal therapeutic effect in patients with pathologically diagnosed stage IIB or above locally advanced cervical cancer. Under the limitations of radiotherapy and surgery conditions in the region, some patients will try neoadjuvant chemotherapy combined with PD-1 antibody therapy before standard radiotherapy, hoping to reduce cancer focus and reduce infiltration. Thereby reducing the scope of radiotherapy, better ensure the efficacy of late radiotherapy and chemotherapy and reduce the side effects of radiotherapy. Judging from the review of such patients, neoadjuvant chemotherapy combined with PD-1 antibody therapy + radical radiotherapy seems to have certain efficacy and tolerance in the near future as expected. No statistical analysis has been done on the long-term survival of patients. This topic intends to treat inoperable locally advanced cervical cancer patients with neoadjuvant chemotherapy combined with PD-1 antibody + radical radiotherapy, and explore the treatment-related toxic and side effects and efficacy of neoadjuvant chemotherapy combined with PD-1 antibody + radical radiotherapy. It is hoped that through this study, it will provide a reference for the comprehensive treatment of inoperable locally advanced cervical cancer that has been pathologically diagnosed in the future.

Conditions

Neoadjuvant Chemotherapy; PD-1 Antibody; Radiotherapy; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  refers to the proportion of patients whose tumors shrink to a certain amount and maintain for a certain period of time (4 weeks after all treatments), including CR+PR cases. CR (complete remission): disappearance of all target lesions, PR (partial remission): reduction of the sum of the length and diameter of the baseline lesions by ≥30%

  4 weeks after all treatments

Secondary Outcomes (3)

• Side effects

  during the procedure

• DFS

  year 1 and year 5

• OS

  year 1 and year 5

Study Arms (1)

neoadjuvant chemotherapy+ PD-1 antibody + radical radiotherapy

EXPERIMENTAL

All patients received three cycles of 21 days each, with chemotherapy on day 1 (nab-paclitaxel 150 mg/m2 plus cisplatin 75 mg/m2) and camrelizumab 200 mg, followed by radical radiotherapy.

Combination Product: neoadjuvant chemotherapy combined with PD-1 antibody + radical radiotherapy

Interventions

neoadjuvant chemotherapy combined with PD-1 antibody + radical radiotherapy COMBINATION_PRODUCT

All patients received three cycles of 21 days each, with chemotherapy on day 1 (nab-paclitaxel 150 mg/m2 plus cisplatin 75 mg/m2) and camrelizumab 200 mg, followed by radical radiotherapy.

neoadjuvant chemotherapy+ PD-1 antibody + radical radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were pathologically diagnosed with cervical squamous cell carcinoma and were assessed as unresectable.

You may not qualify if:

• Any active or present autoimmune disease (eg, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism)

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

Study Sites (1)

Vitalbeam

Shanghai, 200233, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

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 Fu, Dr

  Shanghai Sixth People's Hospital, Shanghai Jiao Tong University

  STUDY CHAIR

Central Study Contacts

Jie Fu, Dr

CONTACT

8602124058972; fujie74@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 26, 2022
• Study Start: August 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)