Clinical trial NCT06786780: Establishment and Validation of Prediction Model of Simultaneous Chemoradiotherapy for Cervical Cancer Organoids
Official title: A Single-Arm, Single-Center, Phase II Study to Evaluate the Predictive Value of Organoids for Radiotherapy and Chemotherapy Efficacy in Cervical Cancer
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Cervical Cancer Treated with Pelvic Radiotherapy
Cervical Cancers
Keywords: Cervical cancer
Concurrent chemoradiotherapy
organoid
Lead sponsor: Chongqing University Cancer Hospital
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: By extracting tumor tissues from cervical squamous cell carcinoma, adenocarcinoma, small cell carcinoma, neuroendocrine carcinoma, clear cell carcinoma, intestinal-type adenocarcinoma, mesonephric adenocarcinoma, and mucinous adenocarcinoma, cervical cancer organoids are constructed. These organoids undergo concurrent chemoradiotherapy experiments, and the results are compared with clinical efficacy to construct a model for predicting clinical concurrent chemoradiotherapy outcomes, which is then used to validate the efficacy of clinical concurrent chemoradiotherapy.
Primary purpose: TREATMENT

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.

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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Primary outcomes:
measure: ORR assessed by Investigator
timeFrame: Up to 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing university Cancer Hospital
Study officials:
affiliation: Chongqing University Cancer Hospital
name: Ling Long, PhD
role: PRINCIPAL_INVESTIGATOR
References: