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

NCT06055738 | Recruiting Phase 2

• 1 other identifier: TangduH-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  3-4 months

Secondary Outcomes (6)

• Complete pathological response (pCR)

  one year

• Major Pathological Response (MPR)

  one year

• R0 resection rate

  one year

• Event-free survival (EFS)

  three years

• Overall survival (OS)

  three years

Study Arms (1)

Zimberelimab combined with albumin-bound paclitaxel and cisplatin

EXPERIMENTAL

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

Drug: Zimberelimab; Drug: Albumin-bound Paclitaxel; Drug: Cisplatin

Interventions

Zimberelimab DRUG

240mg,d1,iv,Q21D

Also known as: GLS-010

Zimberelimab combined with albumin-bound paclitaxel and cisplatin

Albumin-bound Paclitaxel DRUG

260mg/m2,d1,iv,Q21D

Also known as: Paclitaxel

Zimberelimab combined with albumin-bound paclitaxel and cisplatin

Cisplatin DRUG

75mg/m2,d1,iv,Q21D

Also known as: CDDP

Zimberelimab combined with albumin-bound paclitaxel and cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Hongxi Zhao

Xi'an, Shaanxi, 710000, China

RECRUITING

MeSH Terms

Interventions

zimberelimab; Albumin-Bound Paclitaxel; Paclitaxel; Cisplatin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Hongxi Zhao, PhD

  Tangdu Hospital-Air Force Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongxi Zhao, PhD

CONTACT

+8615094088350; zhaohx@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: October 9, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

CN (1)