Trial Title:
Tislelizumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer
NCT ID:
NCT05588219
Condition:
Uterine Cervical Neoplasms
Conditions: Official terms:
Uterine Cervical Neoplasms
Cisplatin
Tislelizumab
Immune Checkpoint Inhibitors
Conditions: Keywords:
Cervical cancer
Tislelizumab
Concurrent chemoradiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Tislelizumab injection[10ml:100mg] will be used beginning with radiotherapy: 200mg/3W for
1 year or disease progression or intolerable toxicity, whichever occurs first.
Arm group label:
Experimental arm
Other name:
Immune checkpoint inhibitors
Intervention type:
Drug
Intervention name:
DDP synchronous with radiotherapy
Description:
DDP 40mg/m2/W, synchronous with radiotherapy, complete at least 4 cycles.
Arm group label:
Experimental arm
Other name:
Cisplatin
Summary:
This study aims to evaluate the efficacy and safety of Tislelizumab combined with
concurrent chemoradiotherapy in the treatment of cervical cancer patients with cervical
mass > 4cm and regional lymph node metastasis, paracervical invasion and regional lymph
node metastasis, stage IIIA, stage IIIB, and stage IVA. To provide a clinical reference
for finding a safe and effective individualized treatment plan to improve the survival
prognosis of locally advanced cervical cancer patients.
Detailed description:
This is a prospective, single-arm, single-center phase II clinical study. The objective
is to evaluate the efficacy and safety of Tislelizumab combined with concurrent
chemoradiotherapy in the treatment of locally advanced cervical cancer. This study was
independently completed by our center. Cervical cancer patients with cervical mass > 4cm
with regional lymph node metastasis, paracervical invasion with regional lymph node
metastasis, stage IIIA, stage IIIB and stage IVA in FIGO stage 2018 were selected as
subjects, and 30 patients were planned to be enrolled. External irradiation 45~50Gy/25f+
Brachytherapy 28~30Gy/4~5f; Chemotherapy: DDP 40mg/m2/W, synchronous with radiotherapy,
complete at least 4 cycles; Tislelizumab: 200mg/3W for 1 year or disease progression or
intolerable toxicity, whichever occurs first.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged 18 to 70 years.
2. The pathological types of cervical cancer confirmed by histopathology were squamous
cell carcinoma, adenocarcinoma and adenosquamous cell carcinoma.
3. In FIGO stage 2018, cervical mass > 4cm with regional lymph node metastasis,
paracervical invasion with regional lymph node metastasis, stage IIIA, stage IIIB,
and stage IVA.
4. Having at least one measurable lesion according to RECIST 1.1.
5. ECOG score 0-1.
6. Expected survival time ≥6 months.
7. Major organ function is normal, that is, meeting the following criteria: blood
routine: HB≥90g/L, ANC≥1.5×109/L, PLT≥80×109/L; Biochemical examination of
ALB≥30g/L, TBIL≤1.5 ULN, ALT and AST≤2.5 ULN, plasma Cr≤1.5 ULN or creatinine
clearance ≥60 ml/min.
8. Menopausal women, or women of childbearing age who meet all the following
conditions: non-lactation, not pregnant, and can take adequate contraceptive
measures during the study treatment.
9. Subjects volunteered to join the study, signed the informed consent, had good
compliance, and cooperated with follow-up.
Exclusion Criteria:
1. Patients have had or currently have other malignant tumors within 5 years.
2. Patients allergic or sensitive to any drug in the study protocol.
3. Patients innate or acquired immune deficiency (e.g. 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.); The subject had
vitiligo. Subjects with asthma require bronchodilators for medical intervention.
5. The presence of active infections requiring systemic treatment.
6. The subject has previously received other PD-1 or PD-L1, or CTLA-4 antibody therapy,
or other drug therapy targeting immunoregulatory receptor preparations.
7. Unrelieved toxic effects above CTCAE grade 1 due to any previous treatment,
excluding alopecia.
8. Patients with a history of myocardial infarction or stroke, unstable angina
pectoris, decompensated heart failure or deep vein thrombosis.
9. Patients with long-term untreated wounds or fractures, major surgical operations or
severe traumatic injuries, fractures or ulcers within 4 weeks.
10. Pregnant or lactating women.
11. Patients with liver and kidney dysfunction.
12. Patients with a history of abuse of psychotropic drugs and unable to abstain or
patients with mental disorders.
13. Patients who have participated in clinical trials of other drugs within 4 weeks.
14. Patients with concomitant diseases that, in the judgment of the investigator,
seriously endanger the patient's safety or affect the patient's completion of the
study.
15. The investigator judged that participation in this study was not conducive to the
maximum benefit of the subjects.
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
Contact:
Last name:
Yong Zhang, PhD
Phone:
13607884001
Email:
zhangyonggx@163.com
Contact backup:
Last name:
Shanshan Ma, PhD
Phone:
13557994302
Email:
mashanshan@gxmu.edu.cn
Start date:
December 1, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Yong Zhang,MD
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/NCT05588219
