Efficacy and Toxicity of Paclitaxel, Cisplatin Combined With Sindilimab in NACT for Locally Advanced Cervical Cancer

NCT04799639 | Completed Phase 2

• 1 other identifier: B2020-201-01
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the safety and efficacy of Sindilimab combined with Paclitaxel and Cisplatin in neoadjuvant chemotherapy for Locally Advanced Cervical Cancer

Conditions

Cervical Cancer; Chemotherapy Effect; Programmed Cell Death 1 Receptor / Antagonists & Inhibitors; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• pathological complete remission rate (pCR) rate

  According to the postoperative pathological results, the pathological complete remission rate (pCR) will be evaluated.

  3 months

Secondary Outcomes (1)

• objective response rate (ORR) (CR + PR)

  3 months

Study Arms (1)

paclitaxel + cisplantin + Sindilimab

EXPERIMENTAL

standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles paclitaxel 150mg/m2，ivdrip,\>3 hours cisplantin 70mg/m2，ivdrip，\>1 hours Sindilimab 200mg，ivdrip, \>0.5 hours

Drug: Sindilimab +paclitaxel+ cisplantin

Interventions

Sindilimab +paclitaxel+ cisplantin DRUG

standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles

paclitaxel + cisplantin + Sindilimab

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 to 65 years with primary cervical cancer;
• Clinical diagnosis of cervical cancer stage IB3 or IIA2 (FIGO stage, 2018). The stage was determined by two associate senior physicians or above after examining the patients;
• no distant organ metastasis, and the short diameter of retroperitoneal lymph nodes was less than 1 cm;
• according to the RECIST version 1.1 criteria, the measurable lesion of the cervix assessed by imaging was \> 3.5 cm;
• histological types includes cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma;
• no radiotherapy, chemotherapy or targeted therapy before;
• the expected survival time was greater than 3 months;
• the ECOG score of the Eastern Cooperative Oncology Group was 0 - 1;
• the function of important organs met the requirements of surgery, chemotherapy and radiotherapy.

You may not qualify if:

• Patients with other malignant tumors;
• Patients is pregnancy or in perinatal period;
• Patients with myocardial infarction or stroke, or unstable angina pectoris, decompensated heart failure, or deep venous thrombosis;
• Patients with NCI-CTCAE 5.0 ≥ grade 2 arrhythmia, any grade of atrial fibrillation, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
• Patients with active pneumonia: hepatitis patients with progressive loss of appetite, general weakness, nausea, acid reflux, anorexia, abdominal distension and other clinical manifestations, abnormal liver function and jaundice such as yellow eyes, yellow urine and other clinical symptoms;
• Patients with liver dysfunction (aspartate/alanine aminotransferase \> 2.5 times the upper limit of the standard);
• Patients with renal insufficiency (serum creatinine \> 2 times the upper limit of the standard);
• History of chronic lung disease with restrictive respiratory dysfunction;
• History of important organ transplantation, history of immune diseases;
• History of severe mental illness, History of cerebral dysfunction;
• history of drug abuse or drug use;
• patients are using immunosuppressive agents, or systemic hormone therapy to achieve the purpose of immunosuppression (dose \> 10 mg prednisone or other effective hormones), and continue to use 2 weeks before enrollment;
• coagulation abnormalities (INR \> 2.0, PT \> 16s), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy, allowing prophylactic use of low-dose aspirin,Low molecular weight heparin;
• Congenital or acquired immunodeficiency (such as HIV infection);
• Received live vaccine within 30 days before the first dose;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University cancer center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jihong Liu, Ph.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: patients will receive intravenous drip of standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: March 16, 2021
• Study Start: March 18, 2021
• Primary Completion: June 17, 2024
• Study Completion: June 24, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)