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Tislelizumab and Radiotherapy for Recurrent Cervical Cancer

Primary Purpose

Recurrent Cervical Carcinoma, Metastatic Cervical Carcinoma, Persistent Cervical Carcinoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Tislelizumab plus radiotherapy

About this trial

This is an interventional treatment trial for Recurrent Cervical Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Lei LiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with recurrent cervical cancer

Arm Description

Patients with recurrent, metastatic and persistent advanced cervical cancer

Outcomes

Primary Outcome Measures

Objective Response Rate

Overall survival is defined as the duration from date of enrollment to the date of death from any cause

Secondary Outcome Measures

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.

Overall survival

Overall survival is defined as the duration from date of enrollment to the date of death from any cause

Adverse Events

Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE)

Full Information

NCT ID

NCT05310383

First Posted

March 26, 2022

Last Updated

April 1, 2022

Sponsor

Lei Li

1. Study Identification

Unique Protocol Identification Number

NCT05310383

Brief Title

Tislelizumab and Radiotherapy for Recurrent Cervical Cancer

Official Title

Combination of Immune Checkpoint Inhibitors Tislelizumab and Radiotherapy for Recurrent, Metastatic and Persistent Advanced Cervical Cancer: A Single-arm, Single-center, Phase 2 Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 27, 2022 (Actual)

Primary Completion Date

March 27, 2023 (Anticipated)

Study Completion Date

March 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lei Li

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with recurrent cervical cancer

Arm Type

Experimental

Arm Description

Patients with recurrent, metastatic and persistent advanced cervical cancer

Intervention Type

Combination Product

Intervention Name(s)

Tislelizumab plus radiotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Objective Response Rate

Description

Overall survival is defined as the duration from date of enrollment to the date of death from any cause

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Progression-free survival (PFS)

Description

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.

Time Frame

12 months

Title

Overall survival

Description

Overall survival is defined as the duration from date of enrollment to the date of death from any cause

Time Frame

24 months

Title

Adverse Events

Description

Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE)

Time Frame

24 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lei Li, M.D.

Phone

86-139-1198-8831

lileigh@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lei Li, M.D.

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lei Li

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lei Li, M.D.

Phone

8613911988831

lileigh@163.com

12. IPD Sharing Statement

Learn more about this trial

Tislelizumab and Radiotherapy for Recurrent Cervical Cancer

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