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

A Single-Arm, Single-Center, Phase II Study to Evaluate the Predictive Value of Organoids for Radiotherapy and Chemotherapy Efficacy in Cervical Cancer

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Cervical Cancers; Cervical Cancer Treated with Pelvic Radiotherapy
• Intervention / Treatment: Combination product: Drug: Cisplatin

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Chongqing, China, 400000
    • Chongqing University Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Combination product: Drug: Cisplatin; Organoids were constructed prior to simultaneous radiochemical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chongqing University Cancer Hospital
• Investigators: Principal Investigator: Ling Long, PhD, Chongqing University Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 23, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Cervical cancer; Concurrent chemoradiotherapy; organoid
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: CQGOG0115; BJHA-CRP-079 (Other Grant/Funding Number: Beiing Health Alliance Charitable Foundation，China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Involving patient privacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No