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Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy

NCT04188860 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-03-15

No results posted yet for this study

Summary

For recurrent or persistent advanced cervical cancer patients, the first-line chemotherapy was based on platinum. However, if they were refractory to platinum-based chemotherapy, there were no other more effective medications or treatment. The marketing of anti-PD-1 antibody has provided an opportunity of curative management. This single arm, open, phase II trial would recruit 34 eligible patients. A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for first 9 patients. If at least total 2 patients achieved complete or partial remission, or at least total 6 patients achieved complete or partial remission or stable disease, the same regimen would be given for rest patients. The primary end is overall response rate (ORR). The second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. A molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.

Conditions

  • Recurrent Cervical Carcinoma
  • Persistent Advanced Cervical Carcinoma
  • Chemotherapy
  • Anti-PD-1 Antibody
  • Immunotherapy

Interventions

DRUG

A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel

A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for all patients: * Camrelizumab: 200 mg every time, every 3 weeks, which would be sustained until the appearance of disease progression on intolerable adverse events, and no more than 24 months * Albumin-bound paclitaxel: 200-300 mg every time, every 3 weeks, no more than 6 courses

Sponsors & Collaborators

  • Lei Li

    lead OTHER

Principal Investigators

  • Lei Li, M.D. · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-06
Primary Completion
2022-01-06
Completion
2022-03-06

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04188860 on ClinicalTrials.gov