NCT07167160

Brief Summary

Efficacy evaluation of camrelizumab combined with chemotherapy for adjuvant treatment of patients with pathologically confirmed lymph node-positive cervical cancer after staging surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
45mo left

Started Mar 2025

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Mar 2025Dec 2029

Study Start

First participant enrolled

March 10, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

December 18, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

September 1, 2025

Last Update Submit

December 10, 2025

Conditions

Cervical CancerImmunochemotherapy

Outcome Measures

Primary Outcomes (1)

  • 3-year disease-free survival rate

    from enrollment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 100 months

Study Arms (1)

chemotherapy group

EXPERIMENTAL
Drug: Camrelizumab combined with chemotherapy

Interventions

Camrelizumab combined with chemotherapyDRUG

Camrelizumab combined with chemotherapy for adjuvant treatment of patients with pathologically confirmed lymph node-positive cervical cancer after staging surgery

chemotherapy group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with cervical cancer staged FIGO2018 IIIC1p or IIIC2p after radical surgery;
  • Positive PD-L1 expression;
  • ECOG score ≤1

You may not qualify if:

  • Positive parametrium or surgical margin;
  • Incomplete radical surgery;
  • Residual target lesions;
  • Active autoimmune disease or autoimmune disease requiring systemic treatment;
  • Previous treatment with immune checkpoint inhibitors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2025

First Posted

September 11, 2025

Study Start

March 10, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2029

Last Updated

December 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)