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

Shanghai Shengdi Pharmaceutical

Status and phase: Active, not recruiting; Phase 2

Conditions: Locally Advanced Cervical Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06237257

SHR-1316-202

Details and patient eligibility

About

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 .

Enrollment: 56 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

SHR-1316 plus concurrent chemoradiotherapy

Experimental group

Treatment:

Drug: Paclitaxel Injection

Radiation: External Beam Radiotherapy (EBRT)/Brachytherapy

Biological: SHR-1316

Drug: Cisplatin Injection/Carboplatin Injection