Cervical AdenocarcinomaPhase 1/2NCT07153952
RT for Adenocarcinoma/Adenosquamous Carcinoma
A Phase 1/2 study testing radiotherapy and Systemic treatment in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study aims to establish a prospective cohort of locally advanced cervical adenocarcinoma to provide a better way to monitor its efficacy and provide precise treatment. The key problems to be solved are as follows: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Radiotherapy
- What is being tested?
- radiotherapy and Systemic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Jan 2028
- Phase
- Phase 1/2
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological diagnosis of cervical adenocarcinoma;
- Age 18-80 years old;
- FIGO 2018 stage IB3-IVA;
- Karnofsky score≥60 points;
- Complete blood count, and comprehensive metabolic panel meet the conditions for CCRT;
- No metal implants in the body, and can perform MRI examination;
- Willing to participate in this study and provide written informed consent.
Who cannot join
- Patients who have received pelvic radiotherapy before;
- Patients whose target tumors have been treated before (chemotherapy, immunotherapy, surgical treatment, etc.);
- Allergy to iodine contrast agent;
- Participating in other clinical studies that may affect the results of this study (determined by the principal investigator);
- Serious diseases that may significantly affect compliance with clinical trials, such as unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, and mental illness that require treatment; g) Other situations that the investigator believes are not suitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Evaluation of the Treatment Response and Prognosis of Cervical Adenocarcinoma/Adenosquamous Carcinoma After Radiotherapy Based on Pathologic Characteristics and Multimodal Imaging: a Prospective, Multicenter Trial
This study aims to establish a prospective cohort of locally advanced cervical adenocarcinoma to provide a better way to monitor its efficacy and provide precise treatment. The key problems to be solved are as follows:
- Establish an observational prospective cohort of locally advanced ADC and randomly divide patients with residual cervical tumors in the primary site after CCRT into the local treatment group (salvage surgery or supplementary radiotherapy) or the systemic treatment group.
- Collect cervical biopsy tissues before and after CCRT in patients with residual cervical tumors, explore the genomic characteristics, and predict whether they can benefit from targeted/immunotherapy in the future.
- Being tested
- radiotherapy, Systemic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
The surgical method is determined by the gynecological oncologist, including total hysterectomy, pelvic exenteration, or radical total hysterectomy. The specific surgical choice needs to be comprehensively judged based on the patient's residual tumor location, size, and other complications. Supplementary radiotherapy is mainly image-guided brachytherapy ± external irradiation. The irradiation range and dose must be comprehensively considered based on the location and size of the residual lesions. The best local treatment plan is jointly determined by gynecological oncologists and radiotherapists.
Systemic treatmentDrug
Systemic treatment regimens include chemotherapy ± targeted therapy ± immunotherapy. According to the NCCN Guidelines (2024.V2), the first-line chemotherapy regimen for persistent, recurrent, or metastatic cervical cancer is preferably carboplatin/paclitaxel and cisplatin/paclitaxel. The addition of immunotherapy can be determined based on the PD-L1 expression level. The specific chemotherapy regimen will be determined by the gynecological oncologist based on the residual tumor site, the number of lesions, and other complications. In addition, if the patient's pathological results indicate HER2 positivity or the genetic test results show PIK3CA mutation, targeted therapy, such as neratinib or apelisimab, can be considered as a second-line regimen after the first-line chemotherapy regimen progresses.
| Study group | Role | What they receive |
|---|---|---|
| Group A: the local treatment group | Experimental | Not described Receives: Radiation: radiotherapy |
| Group B: the systemic treatment group | Active comparator | Not described Receives: Drug: Systemic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor control rate
Measured: Tumor control rate among patients with residual cervical tumors in the two groups 3 months after treatment
Secondary outcomes (2)
progression-free survival
The time from randomization to the occurrence of disease recurrence or death from any cause within 2 years was determined based on the time of the first event. If no such event occurred, the time was determined to the last follow-up.
Measured: 2-year progression-free survival
overall survival
The time interval from randomization to death from any cause within 2 years, or if there was no death, to the last follow-up time
Measured: 2-year overall survival rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Xiamen University, Heilongjiang Provicial Hospital, Liaoning Cancer Hospital & Institute, Women's Hospital School Of Medicine Zhejiang University, Luohe Central Hospital
- Responsible party
- Principal investigator, yanjunfang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153952
- Sponsor's protocol ID
- ATTRACT-Pros
- Status last verified
- Jan 2025
- First submitted
- 11 May 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Treatment Response and Prognosis of Cervical Adenocarcinoma/Adenosquamous Carcinoma After Radiotherapy Based on Pathologic Characteristics and Multimodal Imaging: a Prospective, Multicenter Trial
- ClinicalTrials.gov ID
- NCT07153952
- Acronym / sponsor ID
- ATTRACT-Pros
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Xiamen University, Heilongjiang Provicial Hospital, Liaoning Cancer Hospital & Institute, Women's Hospital School Of Medicine Zhejiang University, Luohe Central Hospital
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 4 Sep 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 study aims to establish a prospective cohort of locally advanced cervical adenocarcinoma to provide a better way to monitor its efficacy and provide precise treatment. The key problems to be solved are as follows:
- Establish an observational prospective cohort of locally advanced ADC and randomly divide patients with residual cervical tumors in the primary site after CCRT into the local treatment group (salvage surgery or supplementary radiotherapy) or the systemic treatment group.
- Collect cervical biopsy tissues before and after CCRT in patients with residual cervical tumors, explore the genomic characteristics, and predict whether they can benefit from targeted/immunotherapy in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: the local treatment group | Experimental | Radiation: radiotherapy |
| Group B: the systemic treatment group | Active comparator | Drug: Systemic treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathological diagnosis of cervical adenocarcinoma;
- Age 18-80 years old;
- FIGO 2018 stage IB3-IVA;
- Karnofsky score≥60 points;
- Complete blood count, and comprehensive metabolic panel meet the conditions for CCRT;
Key exclusion criteria (5 listed)
- Patients who have received pelvic radiotherapy before;
- Patients whose target tumors have been treated before (chemotherapy, immunotherapy, surgical treatment, etc.);
- Allergy to iodine contrast agent;
- Participating in other clinical studies that may affect the results of this study (determined by the principal investigator);
- Serious diseases that may significantly affect compliance with clinical trials, such as unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, and mental illness that require treatment; g) Other situations that the investigator believes are not suitable for participation in this clinical study.
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 |
|---|---|---|
| radiotherapyThe surgical method is determined by the gynecological oncologist, including total hysterectomy, pelvic exenteration, or radical total hysterectomy. The specific surgical choice needs to be comprehensively judged based on the patient's residual tumor location, size, and other complications. Supplementary radiotherapy is mainly image-guided brachytherapy ± external irradiation. The irradiation range and dose must be comprehensively considered based on the location and size of the residual lesions. The best local treatment plan is jointly determined by gynecological oncologists and radiotherapists. | Radiation | Group A: the local treatment group |
| Systemic treatmentSystemic treatment regimens include chemotherapy ± targeted therapy ± immunotherapy. According to the NCCN Guidelines (2024.V2), the first-line chemotherapy regimen for persistent, recurrent, or metastatic cervical cancer is preferably carboplatin/paclitaxel and cisplatin/paclitaxel. The addition of immunotherapy can be determined based on the PD-L1 expression level. The specific chemotherapy regimen will be determined by the gynecological oncologist based on the residual tumor site, the number of lesions, and other complications. In addition, if the patient's pathological results indicate HER2 positivity or the genetic test results show PIK3CA mutation, targeted therapy, such as neratinib or apelisimab, can be considered as a second-line regimen after the first-line chemotherapy regimen progresses. | Drug | Group B: the systemic treatment group |
Primary outcome
Tumor control rate
Time frame: Tumor control rate among patients with residual cervical tumors in the two groups 3 months after treatment
2 secondary outcomes
progression-free survival
Time frame: 2-year progression-free survival
overall survival
Time frame: 2-year overall survival rate
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 4 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing radiotherapy and Systemic treatment in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by Peking Union Medical College 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 7 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Tumor control rate (time frame: Tumor control rate among patients with residual cervical tumors in the two groups 3 months after treatment). 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 4 Sep 2025.