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

NCT ID: NCT06237257

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2025-01-31

Brief Summary

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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 .

Detailed Description

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Conditions

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Locally Advanced Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHR-1316 plus concurrent chemoradiotherapy

Group Type EXPERIMENTAL

SHR-1316

Intervention Type BIOLOGICAL

SHR-1316（Adebrelimab Injection）

Cisplatin Injection/Carboplatin Injection

Intervention Type DRUG

Cisplatin Injection/Carboplatin Injection

External Beam Radiotherapy (EBRT)/Brachytherapy

Intervention Type RADIATION

External Beam Radiotherapy (EBRT)/Brachytherapy

Paclitaxel Injection

Intervention Type DRUG

Paclitaxel Injection.

Interventions

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SHR-1316

SHR-1316（Adebrelimab Injection）

Intervention Type BIOLOGICAL

Cisplatin Injection/Carboplatin Injection

Cisplatin Injection/Carboplatin Injection

Intervention Type DRUG

External Beam Radiotherapy (EBRT)/Brachytherapy

External Beam Radiotherapy (EBRT)/Brachytherapy

Intervention Type RADIATION

Paclitaxel Injection

Paclitaxel Injection.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Shengdi Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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SHR-1316-202

Identifier Type: -

Identifier Source: org_study_id