Tislelizumab and Radiotherapy for Recurrent Cervical Cancer | NCT05310383

Studies
Tislelizumab and Radiotherapy for Recurrent Cervical Cancer

NCT05310383

Sponsor

Lei Li

Status

Unknown status

Last Update Posted

Apr 11, 2022Actual

Enrollment

58Estimated

Phase

Phase 2

Conditions

Recurrent Cervical Carcinoma
Metastatic Cervical Carcinoma
Persistent Cervical Carcinoma
Radiotherapy
Immunotherapy
Anti-programmed Cell Death Receptor 1
Immune Checkpoint Inhibitors
Tislelizumab
Objective Response Rate
Survival Outcomes

Interventions

Tislelizumab plus radiotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 27, 2022Actual

Primary Completion Date

Mar 27, 2023Estimated

Completion Date

Mar 27, 2024Estimated

First Submitted Date

Mar 26, 2022

First Submission Date that Met QC Criteria

Mar 26, 2022

First Posted Date

Apr 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2022

Last Update Posted Date

Apr 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel plus bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Patients with platinum-resistant recurrent ovarian cancer who meet the inclusion criteria, and don't meet any of the exclusion criteria, are enrolled in the study. They will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. The total treatment periods are no more than 6 cycles. Treatment continue until disease progression, intolerable toxicity, or patient refusal. Objective response rates primary objective. Progression-free survival, overall survival, and safety are secondary objectives. The study will enroll a total of 50 patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with recurrent cervical cancer	Experimental	Patients with recurrent, metastatic and persistent advanced cervical cancer	Combination Product: Tislelizumab plus radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tislelizumab plus radiotherapy	Combination Product	During the period of radiotherapy, patients receiveTislelizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W). Tislelizumab 200mg q3W was administered for up to 35 cycles (up to approximately 2 years) after radiotherapy until disease progression or toxicity.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate	Overall survival is defined as the duration from date of enrollment to the date of death from any cause	12 months

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival (PFS)	PFS defined as the time the duration from date of enrollment to the first documented disease progression, or death due to any cause, whichever occurs first.	12 months
Overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient voluntarily participates and signs informed consent
Aged 18 years of age or older
Has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 within 7 days prior to the first dose of study treatment
Has recurrent cervical cancer and controllable local treatment, indicating an indication for radiation therapy
Willing to accept concurrent radiotherapy combined with Tislelizumab
Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the local investigator
Has adequate organ function
Has expected survival time ≥3 months

Exclusion Criteria:

Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
Has a known history of Human Immunodeficiency Virus (HIV) infection，active Hepatitis virus infection and active tuberculosis (TB; Bacillus tuberculosis)
Has known active central nervous system (CNS) metastases and/or uncontrolled, untreated carcinomatous meningitis with elevated intracranial pressure
Has received a major surgery within 4 weeks prior to signing informed consent
Not suitable for radiotherapy
Reassessment of liver and kidney function and blood routine indexes after radiotherapy did not meet the above criteria
Did not meet the other requirements for inclusion by the investigator
Judged unqualified of the enrollment requirements by the researcher according to other conditions

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases

ID	Term
C000707970	tislelizumab
D011878	Radiotherapy