Cervical Cancer
Conditions
Keywords
cervical carcinoma, PD-1, chemoradiotherapy
Brief summary
To evaluate the efficacy and safety of tislelizumab combined with concurrent chemoradiotherapy in first-line treatment of stage IIIC2 cervical cancer.
Detailed description
This is a multicenter, prospective, and randomized phase II clinical trial. Patients assigned to experimental group will receive standard radiotherapy with concomitant cisplatin 40mg/m2 once every week for 5 weeks, combined with tislelizumab (200 mg, day 1) once every 3 weeks until disease progression or intolerable toxicity occurs or one year. Patients assigned to control group will undergo standard radiotherapy with concomitant cisplatin 40mg/m2 once every week for 5 weeks. Compare the efficacy and toxicity of the two regimens in patients with stage IIIC2 cervical cancer.
Interventions
DRUGtislelizumab
standard radiotherapy with concomitant cisplatin 40mg/m2 once every week for 5 weeks, combined with tislelizumab (200 mg, day 1) once every 3 weeks until disease progression or intolerable toxicity occurs or one year.
OTHERconcurrent chemoradiotherapy
standard radiotherapy with concomitant cisplatin 40mg/m2 on day 1 once every week for 5 weeks.
Sponsors
First Affiliated Hospital of Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomized (1:1) to Arm A or Arm B.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
(1)18-70 years old; (2)Histologically confirmed squamous carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix; (3)Patients with 2018 FIGO stage IIIC2 cervical cancer; (4)At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1; (5)Eastern Cooperative Oncology Group score 0-1; (6)No metastatic diseases; (7)Must have an average life expectancy of 6 months; (8)Participants must have normal organ and marrow function as defined below: (hemoglobin ≥90g/L,neutrophils ≥1.5×109/L, platelets ≥80×109/L, ALB≥30g/L, Total bilirubin≤1.5 x institutional upper limit of normal, AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal, Creatinine clearance≥60 mL/min; (9)Patients with menopause, or patients of reproductive potential were required to take effective contraceptive measures for the duration of the study and had a negative pregnancy test result, non-lactating women; (10)Patients volunteered to participate in the study and sign the informed consent.
Exclusion criteria
1. Diagnosed with any other cancer within the past 5 years; 2. Known allergy to any component of the drug; 3. Congenital or acquired immune deficiency (such as HIV infection); 4. The presence of any active, known or suspected autoimmune disease (such as, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, hypothyroidism, etc.); Medical history of vitiligo; asthma which requires bronchodilators for medical intervention; 5. Active infection requiring systemic treatment; 6. Previously treatment with PD-1 and/or PD-L1, or CTLA-4 antibody, or other medications targeting immunomodulatory receptors; 7. Patients with grade\>2 unrelieved toxic reactions (based on National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0) caused by any previous treatment; 8. With a history of myocardial infarction,stroke, unstable angina, decompensated heart failure, or deep vein thrombosis; 9. Long-term uncured wounds or fractures; Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks; 10. Pregnant or lactating women; 11. With metastatic diseases; 12. Liver/renal insufficiency; 13. Those who have a history of psychotropic drug abuse and cannot get rid of it or those with mental disorders; 14. Those who have participated in clinical trials with other drugs within 4 weeks; 15. Patients with concomitant diseases or abnormal test results which interfere with the ability to receive anticancer therapy judged by the investigator; 16. Patients could not gain the maximum benefit from this study judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year progress free survival rate | up to 3 years | Progression-free survival (PFS) is defined as the time between entry into the study and progression of the tumor (in any respect) or death (from any cause). |
| side effect rate | up to 3 years | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate(ORR) | 3 months, after chemoradiotherapy | ORR is defined as the proportion of patients with CR or PR, assessed by RECIST v1.1 per independent central radiologic review. |
| 3-year overall survival rate | up to 3 years | overall survival rate（OS）is calculated from the date of entry into the study to the date of death or the last follow-up visit. |
Countries
China
Contacts
Primary Contactshanshan ma, M.D.
Backup Contactyong zhang, M.D.
Outcome results
None listed