A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer

The Primary purpose of this study is to evaluate the safety of SHR-1316 plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer.

The second purpose of this study is to evaluate the efficacy and PK traits; The exploratory study is to explore the biomarker 、immunogenicity and so on .

Study Overview

• Status: Active, not recruiting
• Conditions: Locally Advanced Cervical Cancer
• Intervention / Treatment: Biological: SHR-1316; Drug: Cisplatin Injection/Carboplatin Injection; Radiation: External Beam Radiotherapy (EBRT)/Brachytherapy; Drug: Paclitaxel Injection

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix；
3. Has locally advanced cervical cancer；
4. At least one measurable lesion ( RECIST version 1.1)；
5. Investigator assess it is suitable for concurrent chemoradiotherapy;
6. Has provided a tissue sample from tumor lesion;
7. Cooperative Oncology Group (ECOG) performance status of 0 or 1;
8. BMI≥18.5kg/m2；
9. Female participants of childbearing potential must agree to use highly effective contraception during the treatment period and for at least 7 months after the last dose of drug，Female participants' HCG must be negative within 3 days prior to enrollment and must be non-lactating.

Exclusion Criteria:

1. Histopathologically confirmed small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma of the cervix；
2. The presence of distant metastatic disease was confirmed by pathology or imaging;
3. has previously undergone hysterectomy (including subtotal hysterectomy) or plan to undergo hysterectomy for cervical cancer, or plan to adopt fertility preservation therapy;
4. In the investigator's judgment, there is a disease (such as severe diabetes, neurological or psychiatric illness, etc.) or any other condition that seriously endangers the subject's safety, confuses the study results, or interferes with the subject's ability to complete the study.

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: SHR-1316 plus concurrent chemoradiotherapy	Biological: SHR-1316; SHR-1316（Adebrelimab Injection）; Drug: Cisplatin Injection/Carboplatin Injection; Cisplatin Injection/Carboplatin Injection; Radiation: External Beam Radiotherapy (EBRT)/Brachytherapy; External Beam Radiotherapy (EBRT)/Brachytherapy; Drug: Paclitaxel Injection; Paclitaxel Injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Type, incidence and grade of drug-related adverse events of grade 3 and above	Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs) include incidence, grade (judged according to NCI-CTCAE V5.0 standards), duration and correlation with study drugs		Up to approximately 30 months
Rate of Suspension and Discontinuation Due to an Adverse Event correlation with study drug		Up to approximately 30 months
Objective Response Rate(ORR)	judged based on RECIST 1.1 criteria according to Investigator's assessment	Up to approximately 60 months
Duration of response (DoR)	judged based on RECIST 1.1 criteria according to Investigator's assessment	Up to approximately 60 months
Progression free survival (PFS)	judged based on RECIST 1.1 criteria according to Investigator's assessment	Up to approximately 60 months
Overall Survival (OS)	judged based on RECIST 1.1 criteria according to Investigator's assessment	Up to approximately 60 months
2-year Progression free survival	judged based on RECIST 1.1 criteria according to Investigator's assessment	Up to approximately 24 months
3-year Overall Survival	judged based on RECIST 1.1 criteria according to Investigator's assessment	Up to approximately 36 months
12-week Complete Response	judged based on RECIST 1.1 criteria according to Investigator's assessment	Up to approximately 4 months
PK traits of SHR-1316: Cmax		Up to approximately 24 months
PK traits of SHR-1316: Tmax		Up to approximately 24 months
PK traits of SHR-1316: AUC0-t		Up to approximately 24 months
PK traits of SHR-1316: AUC0-∞		Up to approximately 24 months
PK traits of SHR-1316: t1/2		Up to approximately 24 months
PK traits of SHR-1316: CL		Up to approximately 24 months
PK traits of SHR-1316: Vss		Up to approximately 24 months
Serum concentration of SHR-1316 at each planned blood collection time point		Up to approximately 24 months

Collaborators and Investigators

• Sponsor: Shanghai Shengdi Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel
• Other Study ID Numbers: SHR-1316-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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