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

Sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05554276

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoadjuvant Chemotherapy PD-1 Antibody Radiotherapy Cervical Cancer	Combination Product: neoadjuvant chemotherapy combined with PD-1 antibody + radical radiotherapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: neoadjuvant chemotherapy+ PD-1 antibody + radical radiotherapy 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 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.

Arm

Intervention/Treatment

Experimental: neoadjuvant chemotherapy+ PD-1 antibody + radical radiotherapy

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

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.

Outcome Measures

Primary Outcome Measures

Objective Response Rate [4 weeks after all treatments]
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%

Secondary Outcome Measures

Safety [during the procedure]
incidence of treatment acute AEs, radiation enteritis, radiation cystitis
DFS [year 1 and year 5]
year 1 and year 5 DFS
OS [year 1 and year 5]
year 1 and year 5 OS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiaojing Yang, Principal Investigator, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

ClinicalTrials.gov Identifier:

NCT05554276

Other Study ID Numbers:

CSH06R101

First Posted:

Sep 26, 2022

Last Update Posted:

Sep 26, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Antibodies

Study Results

No Results Posted as of Sep 26, 2022