A Study of Sintilimab Combined With Concurrent Chemoradiation Therapy in Locally Advanced Cervical Cancer

A Single-Arm, Single-Center Phase II Clinical Study of Sintilimab Combined With Concurrent Chemoradiation Therapy in The Treatment of Stage IIA2 To IVA (2018 FIGO) Locally Advanced Cervical Cancer

This is a single-arm, single-center phase II clinical study to explore the efficacy and safety of sintilimab combined with concurrent chemoradiation therapy as treatment in women with locally advanced cervical cancer.

Study Overview

• Status: Recruiting
• Conditions: Uterine Cervical Neoplasms; Sintilimab
• Intervention / Treatment: Drug: Cisplatin; Drug: Sintilimab; Radiation: External Beam Radiotherapy (EBRT); Radiation: brachytherapy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Longzhen Zhang, MD; Phone Number: 15895236960; Email: jsxyfyzlz@126.com

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • Recruiting
      • The Affiliated Hospital of Xuzhou Medical University
      • Contact: Xiaoxiao Liu, MD; Phone Number: 18752113909; Email: 281656652@qq.com
      • Sub-Investigator: Xiaoxiao Liu, MD
      • Principal Investigator: Longzhen Zhang, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Has high-risk locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage IB3 or FIGO 2018 Stages IIA2-IVA.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1
• Adequate hematological, renal and hepatic functions:Hemoglobin > 9.0 g/dl; Neutrophils > 2000 cells/μl; ANC > 1.5 × 10^9/L;Platelets > 100 × 10^9/L;

Exclusion Criteria:

• Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
• Has a known history of Human Immunodeficiency Virus (HIV) infection.
• Prior malignancies (other than curable non-melanoma skin cancer) within 5 years

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: chemoradiotherapy + Sintilimab; Participants will be given intravenous administration of sintilimab (200mg, q3w), cisplatin(75 mg/m², q3w) and Radiotherapy. After completing 2 cycles of concurrent chemoradiation, the Participants will continue to use 4 cycles of sintilimab (200mg, q3w) and cisplatin(75 mg/m², q3w) as maintenance therapy.	Drug: Cisplatin; IV infusion; Drug: Sintilimab; IV infusion; Radiation: External Beam Radiotherapy (EBRT); Undergo pelvic EBRT; Radiation: brachytherapy; brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate	The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	2 years	Time from diagnosis of disease to disease progression or death due to any cause
Overall survival	2 years	Time from diagnosis of disease of treatment until death due to any cause
Incidence of ADRs and tolerance		1 years

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Xuzhou Medical University
• Investigators: Principal Investigator: Longzhen Zhang, MD, The Affiliated Hospital of Xuzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 24, 2021
• Last Verified: December 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; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: CIBI308XZH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No