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

NCT06786780 | Enrolling By Invitation Phase 2

• 2 other identifiers: CQGOG0115BJHA-CRP-079
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Cervical Cancer Treated with Pelvic Radiotherapy; Cervical Cancers

Keywords

Cervical cancer; Concurrent chemoradiotherapy; organoid

Outcome Measures

Primary Outcomes (1)

• ORR assessed by Investigator

  The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.

  Up to 1 years

Study Arms (1)

Experimental: treatment arm

EXPERIMENTAL

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.

Combination Product: Drug: Cisplatin

Interventions

Drug: Cisplatin COMBINATION_PRODUCT

Organoids were constructed prior to simultaneous radiochemical therapy

Experimental: treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and voluntarily sign written informed consent.
• Women aged ≥18 years at the time of study entry.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2.Life expectancy ≥12 weeks.
• Histologically confirmed cervical cancer.
• 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;
• At least one measurable tumor lesion according to RECIST v1.1 criteria.
• Available archived tumor tissue samples or recent biopsies.
• Adequate organ function.
• 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)

You may not qualify if:

• Subject with other active malignancies within 2 years prior enter the study.
• Subject who cannot receive brachytherapy.
• Active or prior documented autoimmune disease that may relapse.
• History of interstitial lung disease or noninfectious pneumonitis.
• Subject with the clinically significant cardio-cerebrovascular disease.
• History of severe hypersensitivity reactions to other mAbs.
• Prior allogeneic stem cell transplantation or organ transplantation.
• 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.
• Receipt of live attenuated vaccines within 30 days prior to the first dose of the study drug.
• 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).
• 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.

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead

Study Sites (1)

Chongqing university Cancer Hospital

Chongqing, China, 400000, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Ling Long, PhD

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 22, 2025
• Study Start: January 1, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 26, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)