Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy: Multi-Center Trial

Sponsor
Lei Li
Study ID
NCT05290935
Phase
PHASE2
Status
Unknown

Conditions

  • Albumin-bound Paclitaxel
  • Anti-PD-1 Antibody
  • Chemotherapy
  • Immune Checkpoint Inhibitors
  • Persistent Advanced Cervical Carcinoma
  • Recurrent Cervical Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Anti-PD-1 antibody camrelizumab — DRUG
    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 — DRUG
    Albumin-bound paclitaxel: 200-300 mg every time, every 3 weeks, no more than 6 courses

Study Details

This is a updated trial of NCT04188860 as a multi-center study. 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 122 eligible patients. A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for all 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.

Key Dates

Start date
Mar 13, 2022
Status verified
Mar 2022
Primary completion
Dec 13, 2022
Completion
Mar 13, 2024

Study Design

Enrollment
122 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study group
    The patients in the study group would accept the treatment of a combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel.

Primary Outcome Measure

Overall response rate [ Time Frame: One year ]

Central Contacts

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