Clinical trial NCT04188860: Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy
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, Single Center, Open, Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Cervical Carcinoma
Persistent Advanced Cervical Carcinoma
Chemotherapy
Anti-PD-1 Antibody
Immunotherapy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall response rate
timeFrame: One year
Secondary outcomes:
measure: Progression-free survival
timeFrame: One year
measure: Overall survival
timeFrame: One year
measure: Disease control rate
timeFrame: One year
measure: Remission duration
timeFrame: One years
measure: Adverse event rates
timeFrame: One year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: