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Trial Title:
Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer
NCT ID:
NCT05511623
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Tislelizumab
Conditions: Keywords:
cervical carcinoma
PD-1
chemoradiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients will be randomized (1:1) to Arm A or Arm B.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
tislelizumab
Description:
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.
Arm group label:
tislelizumab
Other name:
pd-1 antibody
Intervention type:
Other
Intervention name:
concurrent chemoradiotherapy
Description:
standard radiotherapy with concomitant cisplatin 40mg/m2 on day 1 once every week for 5
weeks.
Arm group label:
concurrent chemoradiotherapy
Other name:
DDP combined with radiotherapy
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Guangxi Medical University
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Start date:
September 1, 2022
Completion date:
December 31, 2027
Lead sponsor:
Agency:
First Affiliated Hospital of Guangxi Medical University
Agency class:
Other
Source:
First Affiliated Hospital of Guangxi Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05511623