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

Sponsor
Lei Li (Other)
Overall Status
Recruiting
CT.gov ID
NCT05290935
Collaborator
(none)
122
1
1
24
5.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Anti-PD-1 antibody camrelizumab
  • Drug: Albumin-bound paclitaxel
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
122 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Anti-PD-1 Antibody Camrelizumab Combined With Albumin-bound Paclitaxel for Recurrent and Persistent Advanced Cervical Cancer Refractory to Platinum-based Chemotherapy: A Single Arm, Multi-Center, Open, Phase II Trial
Actual Study Start Date :
Mar 13, 2022
Anticipated Primary Completion Date :
Dec 13, 2022
Anticipated Study Completion Date :
Mar 13, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Anti-PD-1 antibody camrelizumab
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

Drug: Albumin-bound paclitaxel
Albumin-bound paclitaxel: 200-300 mg every time, every 3 weeks, no more than 6 courses

Outcome Measures

Primary Outcome Measures

  1. Overall response rate [One year]

    The rates of complete and partial remission

Secondary Outcome Measures

  1. Progression-free survival [One year]

    The length of time during and after the treatment of the cancer, that a patient lives with the disease but it does not get worse

  2. Overall survival [One year]

    The length of time from either the date of diagnosis or the start of treatment for the cancer, that patients diagnosed with the disease are still alive

  3. Disease control rate [One year]

    The rates of complete and partial remission, and stable disease

  4. Adverse event rates [One year]

    The rates of adverse events judged by Common Terminology Criteria for Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Female of 18-75 years old

  • Eastern Cooperative Oncology Group score 0-1

  • Pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma, with stage IA1 (with lymph-vascular space invasion) to IVB, which had accepted radical treatment for the purpose of cure

  • Having accepted at least one regimen of platinum-based chemotherapy after the diagnosis of recurrent or persistent advanced cervical cancer, and having an interval of at least 4 weeks since fulfilling the last treatment regimen

  • At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1

  • Anticipative survival period of 3 months or more

  • Lab testing within reference ranges

  • With appropriate contraception

  • Provided consents of participating the trial

Exclusion Criteria:
  • With brain metastasis

  • With addiction to psychiatric medications or with mental disorders

  • With following history and/or complications: autoimmune disease; systematic utilization of corticosteroids (with equivalent of prednison of > 10 mg/day) or other immunosuppressors within 14 days; utilization of antitumor vaccine or other immunostimulation treatment with 3 months; exposure to PD-1 antibody, or PD-L1 antibody, or PD-L2 antibody, or cytotoxic T lymphocyte-associated antigen-4 antibody; history of other malignancies; pulmonary tuberculosis; interstitial pneumonia or related history; active hepatitis; positive testing of human immunodeficiency

  • With adverse effects more than Common Terminology Criteria for Adverse Events grade 1 (except for alopecia), which caused by previous anti-tumor treatment

  • With infective disease which need systematic treatment within 14 days

  • With severe open trauma, fracture or major surgery with past 4 weeks

  • With potential allergy or intolerance to study regimens

  • Not eligible for the study judged by researchers

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lei Li Beijing Beijing China 100730

Sponsors and Collaborators

  • Lei Li

Investigators

  • Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05290935
Other Study ID Numbers:
  • REPACC-3
First Posted:
Mar 22, 2022
Last Update Posted:
Mar 22, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2022