Clinical trial NCT06055738: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Locally Advanced Cervical Cancer
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Voluntary participation in clinical research.
2. Age ≥18 years old, female.
3. Squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix confirmed by histology/cytology.
4. Previously untreated locally advancedcervical cancer (2018 FIGO stage IB3, IIA2) .
5. At least one measurable lesion was suitable for target lesion according to RECIST v1.1 .
6. Within 14 days before the first treatment, the major organ functions were basically normal.
7. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1;
8. Subjects agree to provide sufficient tumor tissue samples for PD-L1 expression detection;
9. 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.
10. 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:

1. Patients with active autoimmune disease or a history of autoimmune disease.
2. Previous history of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation).
3. 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).
4. 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.
5. 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.
6. 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.
7. Symptomatic congestive heart failure (New York Heart Association class II-IV) Arrhythmias with poorly controlled symptoms.
8. Active pulmonary tuberculosis, receiving anti-tuberculosis treatment.
9. Interstitial lung disease.
10. 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.
11. Central nervous system metastasis, leptomeningeal metastasis, spinal cord compression, or leptomeningeal disease.
12. Human immunodeficiency virus (HIV) infection, known syphilis infection.
13. Have received live vaccine within 4 weeks of the first use of the experimental drug, or plan to receive live vaccine during the study.
14. Known or suspected allergy to the trial drug or any drug related to the trial.
15. Pregnant or lactating women.
16. There were other conditions deemed by the investigator to be inappropriate for enrollment.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 3-4 months
Secondary outcomes:
measure: Complete pathological response (pCR)
timeFrame: one year
measure: Major Pathological Response (MPR)
timeFrame: one year
measure: R0 resection rate
timeFrame: one year
measure: Event-free survival (EFS)
timeFrame: three years
measure: Overall survival (OS)
timeFrame: three years
measure: Adverse Events
timeFrame: three years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Hongxi Zhao
state: Shaanxi
Study officials:
affiliation: Tangdu Hospital, Air Force Medical University
name: Hongxi Zhao, PhD
role: PRINCIPAL_INVESTIGATOR
References: