Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy

NCT04188860 | Completed Phase 2 DMC

• 1 other identifier: REPACC-2
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  The rates of complete and partial remission

  One year

Secondary Outcomes (5)

• Progression-free survival

  One year

• Overall survival

  One year

• Disease control rate

  One year

• Remission duration

  One years

• Adverse event rates

  One year

Study Arms (1)

Study group

EXPERIMENTAL

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

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

Interventions

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

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

Study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: December 6, 2019
• Primary Completion: January 6, 2022
• Study Completion: March 6, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Two year
• Access Criteria: Public reports

Locations

CN (1)