Establishment and Validation of Prediction Model of Simultaneous Chemoradiotherapy for Cervical Cancer Organoids

NCT ID: NCT06786780

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2026-06-01

Brief Summary

This is a single-arm, single-center, open-label, Phase II study aimed at assessing the efficacy of organoids in predicting the response to radiotherapy and chemotherapy in cervical cancer

Detailed Description

By constructing cervical cancer organoids, establishing a radiochemotherapy prediction model based on organoids, and exploring radiotherapy resistance-related molecules as new therapeutic targets for locally advanced cervical cancer, the feasibility and effectiveness are assessed. Utilizing the constructed model for molecular mechanism discussions and effective drug screening, new avenues for the treatment of cervical cancer patients with radiochemotherapy resistance are sought.

Conditions

Cervical Cancer Treated with Pelvic Radiotherapy; Cervical Cancers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: treatment arm

Participants receive concurrent chemoradiotherapy, including external beam radiation therapy (EBRT) or brachytherapy. Cisplatin is administered at a dose of 100mg/m² every three weeks, with two doses given during the radiotherapy period, totaling a dose of 200mg/m², or cisplatin at a dose of 40mg/m² once a week, for approximately six weeks of treatment, totaling a dose of 240mg/m². Treatment continues until intolerable toxicity occurs or the investigator determines that the subject can no longer benefit. Before concurrent chemoradiotherapy, cervical cancer tumor tissue or ascites are collected to construct organoids for concurrent chemoradiotherapy experiments. After disease progression, cervical cancer tissue or ascites are collected to construct organoids for drug screening experiments.

Group Type: EXPERIMENTAL

Drug: Cisplatin

Intervention Type: COMBINATION_PRODUCT

Organoids were constructed prior to simultaneous radiochemical therapy

Interventions

Drug: Cisplatin

Organoids were constructed prior to simultaneous radiochemical therapy

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

Able to understand and voluntarily sign written informed consent.

1. Women aged ≥18 years at the time of study entry.

2. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2.Life expectancy ≥12 weeks.

3. Histologically confirmed cervical cancer.

4. Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma，villous duct carcinoma, invasive mucinous multilayer carcinoma, gastric adenocarcinoma, mesrenal duct carcinoma, clear cell carcinoma, serous carcinoma, endometrioid adenocarcinoma and small cell carcinoma，Intestinal-type adenocarcinoma of the cervix;

5. At least one measurable tumor lesion according to RECIST v1.1 criteria.

6. Available archived tumor tissue samples or recent biopsies.

7. Adequate organ function.

8. For fertile women with negative serum pregnancy and effective contraception within 7 days before administration (until 120 days after the last administration of the study drug and at least 180 days after radiotherapy)

Exclusion Criteria

1. Subject with other active malignancies within 2 years prior enter the study.

2. Subject who cannot receive brachytherapy.

3. Active or prior documented autoimmune disease that may relapse.

4. History of interstitial lung disease or noninfectious pneumonitis.

5. Subject with the clinically significant cardio-cerebrovascular disease.

6. History of severe hypersensitivity reactions to other mAbs.

7. Prior allogeneic stem cell transplantation or organ transplantation.

8. Subjects who require systemic treatment with glucocorticoid (>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior enter the study.

9. Receipt of live attenuated vaccines within 30 days prior to the first dose of the study drug.

10. Prior exposure to any experimental antitumor vaccines, or any agent targeting T-cell costimulation or immune checkpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-CD137 or anti-OX40 antibody, etc).

11. Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the study drug or interpretation of subject safety or study results.

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• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chongqing University Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ling Long, PhD

Role: PRINCIPAL_INVESTIGATOR

Chongqing University Cancer Hospital

Locations

Chongqing university Cancer Hospital

Chongqing, China, China

Countries

China

Other Identifiers

BJHA-CRP-079

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CQGOG0115

Identifier Type: -

Identifier Source: org_study_id