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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Cancer; Chemotherapy Effect; Neoadjuvant Therapy; Programmed Cell Death 1 Receptor / Antagonists & Inhibitors
• Intervention / Treatment: Drug: Sindilimab +paclitaxel+ cisplantin

Detailed Description

A total of 47 patients will be enrolled in this study. After screening, patients will receive intravenous drip of standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles. CT/MR of chest, upper and lower abdomen and pelvic MR will be performed before treatment and 2 weeks after the 3rd cycle chemotherapy. The objective response rate (ORR) (CR + PR) is evaluated by comparing with baseline based on RECISTv1.1. Radical surgery will be performed after NACT. According to the postoperative pathological results, the pathological complete remission rate (pCR) will be evaluated. The adverse events will be continuously monitored during treatment until 30 days after chemotherapy. Toxic adverse events is evaluated according to NCI-CTCAEv5.0 criteria.

• Study Type: Interventional
• Enrollment (Anticipated): 47
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jihong Liu, Ph D; Phone Number: +86‭13826299236; Email: liujh@sysucc.org.cn
• Study Contact Backup: Name: Ting Wan, MD; Phone Number: +86‭13824444081‬; Email: wanting@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Patients aged 18 to 65 years with primary cervical cancer;
2. 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;
3. no distant organ metastasis, and the short diameter of retroperitoneal lymph nodes was less than 1 cm;
4. according to the RECIST version 1.1 criteria, the measurable lesion of the cervix assessed by imaging was > 3.5 cm;
5. histological types includes cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma;
6. no radiotherapy, chemotherapy or targeted therapy before;
7. the expected survival time was greater than 3 months;
8. the ECOG score of the Eastern Cooperative Oncology Group was 0 - 1;
9. the function of important organs met the requirements of surgery, chemotherapy and radiotherapy.

Exclusion Criteria:

1. Patients with other malignant tumors;
2. Patients is pregnancy or in perinatal period;
3. Patients with myocardial infarction or stroke, or unstable angina pectoris, decompensated heart failure, or deep venous thrombosis;
4. 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;
5. 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;
6. Patients with liver dysfunction (aspartate/alanine aminotransferase > 2.5 times the upper limit of the standard);
7. Patients with renal insufficiency (serum creatinine > 2 times the upper limit of the standard);
8. History of chronic lung disease with restrictive respiratory dysfunction;
9. History of important organ transplantation, history of immune diseases;
10. History of severe mental illness, History of cerebral dysfunction;
11. history of drug abuse or drug use;
12. 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;
13. 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;
14. Congenital or acquired immunodeficiency (such as HIV infection);
15. Received live vaccine within 30 days before the first dose;
16. Unable or unwilling to sign the informed consent form or comply with the study requirements;
17. Have a history, disease or laboratory abnormalities that may interfere with the test results or prevent the subject from participating in the study, or the investigator believes that participating in the study is not in the best benefit of the subject.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: paclitaxel + cisplantin + Sindilimab; 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; standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pathological complete remission rate (pCR) rate	According to the postoperative pathological results, the pathological complete remission rate (pCR) will be evaluated.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective response rate (ORR) (CR + PR)	The objective response rate (ORR) (CR + PR) is evaluated by comparing with baseline based on RECISTv1.1.	3 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Jihong Liu, Ph.D., Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: March 14, 2021
• First Submitted That Met QC Criteria: March 14, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 14, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: B2020-201-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No