Cervical Cancer Treated with Pelvic RadiotherapyPhase 2ECCONCT06786780
Establishment and Validation of Prediction Model of Simultaneous Chemoradiotherapy for Cervical Cancer Organoids
A Phase 2 study testing Drug: Cisplatin in people with Cervical Cancer Treated with Pelvic Radiotherapy and Cervical Cancers, run by Chongqing University Cancer Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer Treated with Pelvic Radiotherapy, Cervical Cancers
- What is being tested?
- Drug: Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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.
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- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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
Read the 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.
- Being tested
- Drug: Cisplatin
- Keywords
- Cervical cancer, Concurrent chemoradiotherapy, organoid
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: CisplatinCombination product
Organoids were constructed prior to simultaneous radiochemical therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR assessed by Investigator
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.
Measured: Up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Jan 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer Treated with Pelvic RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ling Long, PhD, Principal investigator, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786780
- Sponsor's protocol ID
- CQGOG0115
- Other IDs
- BJHA-CRP-079
- Acronym
- ECCO
- Status last verified
- Dec 2024
- First submitted
- 16 Jan 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Involving patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06786780
- Acronym / sponsor ID
- ECCO / CQGOG0115
- Keywords
- Cervical cancer, Concurrent chemoradiotherapy, organoid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: treatment arm | Experimental | Combination Product: Drug: CisplatinParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug: CisplatinOrganoids were constructed prior to simultaneous radiochemical therapy | Combination product | Experimental: treatment arm |
Primary outcome
ORR assessed by Investigator
Time frame: Up to 1 years
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No. Involving patient privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ling Long, PhD principal investigator
Chongqing University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug: Cisplatin in people with Cervical Cancer Treated with Pelvic Radiotherapy and Cervical Cancers, run by Chongqing University Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR assessed by Investigator (time frame: Up to 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.