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Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of LACC

Primary Purpose

Locally Advanced Cervical Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Zimberelimab
Albumin-bound Paclitaxel
Cisplatin
Sponsored by
Tang-Du Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Cervical Cancer

Eligibility Criteria

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

Inclusion Criteria: Voluntary participation in clinical research. Age ≥18 years old, female. Squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix confirmed by histology/cytology. Previously untreated locally advancedcervical cancer (2018 FIGO stage IB3, IIA2) . At least one measurable lesion was suitable for target lesion according to RECIST v1.1 . Within 14 days before the first treatment, the major organ functions were basically normal. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1; Subjects agree to provide sufficient tumor tissue samples for PD-L1 expression detection; If hepatitis B surface antigen (HBsAg) is positive and/or hepatitis B core antibody (HBcAb) is positive, hepatitis B virus DNA (HBV DNA) is detected, HBV DNA < 104 copies /ml or < 2000IU/mL can be enrolled. Or those who had received antiviral therapy for at least 4 weeks before the first dose of study drug and were willing to continue antiviral therapy during the study were eligible for enrollment. Those with HCV antibody positive should be excluded. Subjects of childbearing age and their sexual partners agreed to consent to contraceptive use after signing an informed consent form, during treatment and for at least 6 months after the last dose of the study intervention. Exclusion Criteria: Patients with active autoimmune disease or a history of autoimmune disease. Previous history of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation). Use of immunosuppressive drugs within 14 days prior to treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., not more than 10 mg/ day of prednisolone or another corticosteroid at the physiological dose of the drug). Previous treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, or anti-lymphocyte antigen 4 (CTLA-4) antibody. Arterial or venous thromboembolic events within the previous 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein embolism or any other major thromboembolism, implantable venous access port or catheter-derived thrombosis, or superficial venous thrombosis. Except for patients with stable thrombus after conventional anticoagulant therapy, prophylactic use of low-dose low molecular weight heparin was allowed. Previous history of gastrointestinal perforation, gastrointestinal fistula, genital fistula (such as vesicovaginal fistula, urethrovaginal fistula, vesicovaginal fistula, etc.); Patients were allowed if the perforation or fistula had been treated with diversion surgery, resection, or repair, and the disease was recovered or relieved as judged by the investigator. Symptomatic congestive heart failure (New York Heart Association class II-IV) Arrhythmias with poorly controlled symptoms. Active pulmonary tuberculosis, receiving anti-tuberculosis treatment. Interstitial lung disease. Severe infections that are active or poorly controlled clinically. Severe infection within 3 weeks before treatment, including but not limited to patients hospitalized for complications of infection, bacteremia, or severe pneumonia. Central nervous system metastasis, leptomeningeal metastasis, spinal cord compression, or leptomeningeal disease. Human immunodeficiency virus (HIV) infection, known syphilis infection. Have received live vaccine within 4 weeks of the first use of the experimental drug, or plan to receive live vaccine during the study. Known or suspected allergy to the trial drug or any drug related to the trial. Pregnant or lactating women. There were other conditions deemed by the investigator to be inappropriate for enrollment.

Sites / Locations

  • Hongxi ZhaoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zimberelimab combined with albumin-bound paclitaxel and cisplatin

Arm Description

Zimberelimab combined with albumin-bound paclitaxel and cisplatin in neoadjuvant treatment of locally advanced cervical cancer

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
Objective response rate based on RECIST v1.1, ORR was defined as the ratio of best complete response (CR) and partial response (PR) recorded from the start of treatment to the preoperative evaluation

Secondary Outcome Measures

Complete pathological response (pCR)
Complete pathological response (pCR) was defined as the proportion of all surgical patients in whom no viable tumor cells were found in the resected specimen.
Major Pathological Response (MPR)
Major pathological response (MPR) was defined as the proportion of patients with ≤10% residual viable tumor cells in the resected specimen among all surgical patients.
R0 resection rate
R0 resection rate: defined as the proportion of patients undergoing surgical excision who had a negative margin of surgical specimens
Event-free survival (EFS)
Event-free survival (EFS) was defined as the time from the start of treatment to the first occurrence of any of the following events: disease progression beyond surgical treatment, local or distant recurrence, death from any cause, etc.
Overall survival (OS)
Overall survival (OS) : defined as the time between the initiation of treatment and death from any cause.
Adverse Events
Based on NCI-CTC AE v5.0

Full Information

First Posted
September 20, 2023
Last Updated
September 20, 2023
Sponsor
Tang-Du Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06055738
Brief Title
Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of LACC
Official Title
An Exploratory Clinical Study of Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of Locally Advanced Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2023 (Anticipated)
Primary Completion Date
December 30, 2026 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tang-Du Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a prospective, single arm, phase II clinical study to evaluate the efficacy and safety of Zimberelimab combined with albumin-bound paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer.
Detailed Description
This study will enroll patients with IB3 and IIA2 locally advanced cervical cancer who received three cycles of neoadjuvant Zimberelimab combined with albumin-bound paclitaxel and cisplatin to evaluate the efficacy and safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zimberelimab combined with albumin-bound paclitaxel and cisplatin
Arm Type
Experimental
Arm Description
Zimberelimab combined with albumin-bound paclitaxel and cisplatin in neoadjuvant treatment of locally advanced cervical cancer
Intervention Type
Drug
Intervention Name(s)
Zimberelimab
Other Intervention Name(s)
GLS-010
Intervention Description
240mg,d1,iv,Q21D
Intervention Type
Drug
Intervention Name(s)
Albumin-bound Paclitaxel
Other Intervention Name(s)
Paclitaxel
Intervention Description
260mg/m2,d1,iv,Q21D
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
CDDP
Intervention Description
75mg/m2,d1,iv,Q21D
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Objective response rate based on RECIST v1.1, ORR was defined as the ratio of best complete response (CR) and partial response (PR) recorded from the start of treatment to the preoperative evaluation
Time Frame
3-4 months
Secondary Outcome Measure Information:
Title
Complete pathological response (pCR)
Description
Complete pathological response (pCR) was defined as the proportion of all surgical patients in whom no viable tumor cells were found in the resected specimen.
Time Frame
one year
Title
Major Pathological Response (MPR)
Description
Major pathological response (MPR) was defined as the proportion of patients with ≤10% residual viable tumor cells in the resected specimen among all surgical patients.
Time Frame
one year
Title
R0 resection rate
Description
R0 resection rate: defined as the proportion of patients undergoing surgical excision who had a negative margin of surgical specimens
Time Frame
one year
Title
Event-free survival (EFS)
Description
Event-free survival (EFS) was defined as the time from the start of treatment to the first occurrence of any of the following events: disease progression beyond surgical treatment, local or distant recurrence, death from any cause, etc.
Time Frame
three years
Title
Overall survival (OS)
Description
Overall survival (OS) : defined as the time between the initiation of treatment and death from any cause.
Time Frame
three years
Title
Adverse Events
Description
Based on NCI-CTC AE v5.0
Time Frame
three years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Voluntary participation in clinical research. Age ≥18 years old, female. Squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix confirmed by histology/cytology. Previously untreated locally advancedcervical cancer (2018 FIGO stage IB3, IIA2) . At least one measurable lesion was suitable for target lesion according to RECIST v1.1 . Within 14 days before the first treatment, the major organ functions were basically normal. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1; Subjects agree to provide sufficient tumor tissue samples for PD-L1 expression detection; If hepatitis B surface antigen (HBsAg) is positive and/or hepatitis B core antibody (HBcAb) is positive, hepatitis B virus DNA (HBV DNA) is detected, HBV DNA < 104 copies /ml or < 2000IU/mL can be enrolled. Or those who had received antiviral therapy for at least 4 weeks before the first dose of study drug and were willing to continue antiviral therapy during the study were eligible for enrollment. Those with HCV antibody positive should be excluded. Subjects of childbearing age and their sexual partners agreed to consent to contraceptive use after signing an informed consent form, during treatment and for at least 6 months after the last dose of the study intervention. Exclusion Criteria: Patients with active autoimmune disease or a history of autoimmune disease. Previous history of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation). Use of immunosuppressive drugs within 14 days prior to treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., not more than 10 mg/ day of prednisolone or another corticosteroid at the physiological dose of the drug). Previous treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, or anti-lymphocyte antigen 4 (CTLA-4) antibody. Arterial or venous thromboembolic events within the previous 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein embolism or any other major thromboembolism, implantable venous access port or catheter-derived thrombosis, or superficial venous thrombosis. Except for patients with stable thrombus after conventional anticoagulant therapy, prophylactic use of low-dose low molecular weight heparin was allowed. Previous history of gastrointestinal perforation, gastrointestinal fistula, genital fistula (such as vesicovaginal fistula, urethrovaginal fistula, vesicovaginal fistula, etc.); Patients were allowed if the perforation or fistula had been treated with diversion surgery, resection, or repair, and the disease was recovered or relieved as judged by the investigator. Symptomatic congestive heart failure (New York Heart Association class II-IV) Arrhythmias with poorly controlled symptoms. Active pulmonary tuberculosis, receiving anti-tuberculosis treatment. Interstitial lung disease. Severe infections that are active or poorly controlled clinically. Severe infection within 3 weeks before treatment, including but not limited to patients hospitalized for complications of infection, bacteremia, or severe pneumonia. Central nervous system metastasis, leptomeningeal metastasis, spinal cord compression, or leptomeningeal disease. Human immunodeficiency virus (HIV) infection, known syphilis infection. Have received live vaccine within 4 weeks of the first use of the experimental drug, or plan to receive live vaccine during the study. Known or suspected allergy to the trial drug or any drug related to the trial. Pregnant or lactating women. There were other conditions deemed by the investigator to be inappropriate for enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongxi Zhao, PhD
Phone
+8615094088350
Email
zhaohx@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongxi Zhao, PhD
Organizational Affiliation
Tangdu Hospital, Air Force Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hongxi Zhao
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongxi Zhao, PhD
Phone
+8615094088350
Email
zhaohx@fmmu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of LACC

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