Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy

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, Single Center, Open, Phase II Trial

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy; Recurrent Cervical Carcinoma; Immunotherapy; Anti-PD-1 Antibody; Persistent Advanced Cervical Carcinoma
• Intervention / Treatment: Drug: A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Lei Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate	The rates of complete and partial remission	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	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	One year
Overall survival	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.	One year
Disease control rate	The rates of complete and partial remission, and stable disease	One year
Remission duration	The duration of complete and partial remission	One years
Adverse event rates	The rates of adverse events judged by Common Terminology Criteria for Adverse Events	One year

Collaborators and Investigators

• Sponsor: Lei Li

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 6, 2019
• Primary Completion (ACTUAL): January 6, 2022
• Study Completion (ACTUAL): March 6, 2022

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (ACTUAL): December 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 12, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Carcinoma; Recurrence; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Antibodies; Albumin-Bound Paclitaxel
• Other Study ID Numbers: REPACC-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data will be available by public reports.
• IPD Sharing Time Frame: Two year
• IPD Sharing Access Criteria: Public reports
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No