Albumin-bound Paclitaxel, Anti-PD-1 Antibody, Chemotherapy, Immune Checkpoint Inhibitors, Persistent Advanced Cervical Carcinoma, Recurrent Cervical Carcinoma
Conditions
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.
Interventions
DRUGAnti-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
DRUGAlbumin-bound paclitaxel
Albumin-bound paclitaxel: 200-300 mg every time, every 3 weeks, no more than 6 courses
Sponsors
Lei Li
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | One year | The rates of complete and partial remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Disease control rate | One year | The rates of complete and partial remission, and stable disease |
| Adverse event rates | One year | The rates of adverse events judged by Common Terminology Criteria for Adverse Events |
Countries
China
Contacts
Primary ContactLei Li, M.D.
Outcome results
None listed