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

NCT06237257 | Active Not Recruiting Phase 2

• 1 other identifier: SHR-1316-202
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Locally Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Type, incidence and grade of drug-related adverse events of grade 3 and above

  Up to approximately 24 months

Secondary Outcomes (17)

• 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)

  Up to approximately 60 months

• Duration of response (DoR)

  Up to approximately 60 months

• Progression free survival (PFS)

  Up to approximately 60 months

Study Arms (1)

SHR-1316 plus concurrent chemoradiotherapy

EXPERIMENTAL

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

Interventions

SHR-1316 BIOLOGICAL

SHR-1316（Adebrelimab Injection）

SHR-1316 plus concurrent chemoradiotherapy

Cisplatin Injection/Carboplatin Injection DRUG

Cisplatin Injection/Carboplatin Injection

SHR-1316 plus concurrent chemoradiotherapy

External Beam Radiotherapy (EBRT)/Brachytherapy RADIATION

External Beam Radiotherapy (EBRT)/Brachytherapy

SHR-1316 plus concurrent chemoradiotherapy

Paclitaxel Injection DRUG

Paclitaxel Injection.

SHR-1316 plus concurrent chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent
• Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix；
• Has locally advanced cervical cancer；
• At least one measurable lesion ( RECIST version 1.1)；
• Investigator assess it is suitable for concurrent chemoradiotherapy;
• Has provided a tissue sample from tumor lesion;
• Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• BMI≥18.5kg/m2；
• 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.

You may not qualify if:

• Histopathologically confirmed small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma of the cervix；
• The presence of distant metastatic disease was confirmed by pathology or imaging;
• has previously undergone hysterectomy (including subtotal hysterectomy) or plan to undergo hysterectomy for cervical cancer, or plan to adopt fertility preservation therapy;
• 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.

Sponsors & Collaborators

• Shanghai Shengdi Pharmaceutical Co., Ltd: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Interventions

Cisplatin; Carboplatin; Paclitaxel

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: March 20, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-04

Locations

CN (1)