Tests whether tumor organoids can predict cervical cancer treatment response
Tests whether lab-grown tumor models predict response to cisplatin with radiotherapy in cervical cancer.
Plain-language title generated from the registry record
Registry title: Establishment and Validation of Prediction Model of Simultaneous Chemoradiotherapy for Cervical Cancer Organoids
Key facts
- Where
- Chongqing, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 or older with confirmed cervical cancer who have at least one tumor that can be measured. It tests whether lab-grown tumor models (organoids) can predict how well radiotherapy and chemotherapy work.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Cervical cancer confirmed by tissue testing (several cell types are listed, such as squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma), with at least one tumor lesion that can be measured by RECIST v1.1.
- Earlier treatment
- Must not have had experimental anti-tumor vaccines or drugs targeting T-cell costimulation or immune checkpoints (for example anti-PD-1, anti-PD-L1, anti-CTLA-4). Must not have had a live attenuated vaccine in the last 30 days.
Main reasons for not taking part
- Another active cancer within the last 2 years
- Cannot receive brachytherapy
- Autoimmune disease that is active or may come back
- History of interstitial lung disease or non-infectious pneumonitis
- Earlier stem cell or organ transplant
Read by machine on 9 November 2026.
Where in China
- Chongqing University Cancer HospitalChongqing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chongqing University Cancer Hospital
- Trial code
- NCT06786780
- Record updated
- 26 March 2025
- Original description
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 cancerRead full original descriptionShow less
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
Inclusion: 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).
Exclusion: Subject with other active malignancies within 2 years prior enter the study; Active or prior documented autoimmune disease that may relapse; 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); History of interstitial lung disease or noninfectious pneumonitis; Subject with the clinically significant cardio-cerebrovascular disease; History of severe hypersensitivity reactions to other mAbs; 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; -; Subject who cannot receive brachytherapy.