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

Chongqing University Cancer Hospital

Status and phase: Invitation-only; Phase 2

Conditions: Cervical Cancer Treated with Pelvic Radiotherapy; Cervical Cancers

Treatments: Combination Product: Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT06786780

CQGOG0115

BJHA-CRP-079 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Experimental: treatment arm

Experimental group

Description:

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.

Treatment:

Combination Product: Drug: Cisplatin