Clinical trial · Interventional
Establishment and Validation of Prediction Model of Simultaneous Chemoradiotherapy for Cervical Cancer Organoids
A Single-Arm, Single-Center, Phase II Study to Evaluate the Predictive Value of Organoids for Radiotherapy and Chemotherapy Efficacy in Cervical Cancer
NCT06786780CI-TRIAL-00087720ECCOenrolling by invitationPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancers | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer Treated with Pelvic Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug: Cisplatin | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: treatment arm
- 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.
- interventionNames
- Combination Product: Drug: Cisplatin
Primary outcomes (1)
- measure
- ORR assessed by Investigator
- timeFrame
- Up to 1 years
- description
- The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
\-References
Publications (0)
Data not yet available
No reference posted for this study.