Personalized Cancer TreatmentNCT06232213
Clinical Study of Individualized Treatment of Relapsed or Drug-resistant Advanced Gynecological Tumors Guided by PTC Model
An observational study of Personalized Cancer Treatment, run by Hua Li at 1 site in China.
Trial summary
The clinical treatment of patients with resistant/relapsed/advanced gynecological malignancies is very difficult, and the difficulty lies in the selection of effective drugs. This study was a cohort study of recurrent/drug-resistant advanced ovarian high-grade serous carcinoma and advanced/recurrent endometrial… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Personalized Cancer Treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Recurrent/drug-resistant and advanced ovarian high-grade serous carcinoma and advanced/recurrent endometrial adenocarcinoma were treated at Beijing Chaoyang Hospital.
Who may be able to join
- Age ≥18 years, ≤80 years
- Recurrent/drug-resistant gynecological tumors include: ① patients with advanced high-grade ovarian serous cancer whose tumor is uncontrolled or recurrent within 6 months after receiving platinum-based chemotherapy; ② Advanced ovarian high-grade serous cancer patients with platinum resistance at first treatment; ③ Patients with advanced or recurrent endometrial adenocarcinoma.
- Life expectancy > 6 months;
- Malignant tumors that are not being treated by other systems or are in an active phase;
- Have at least one measurable target lesion according to RECIST1.1 criteria;
- Specimen requirements: fresh specimens with sufficient cell culture, including tissue samples and abdominal effusion;
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- Physical strength score: ECOG 0-2;
- Major organ functions must meet clinical treatment requirements:
- Blood routine: neutrophil (ANC) ≥1.5x109/L; Platelet count (PLT) ≥90x109/L; Hemoglobin (Hb) ≥90g/L; ② Blood biochemistry: total bilirubin (TBIL) ≤1.5x upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5xULN; Urea nitrogen (BUN) and creatinine (Cr) ≤1.5 x ULN
- Heart color ultrasound: left ventricular ejection fraction (LVEF) ≥55%;
- ④ 12-lead ECG: Fridericia method corrected QT period (QTcF) < 470 msec. (9) Consent to abstinence from sex or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment for female patients who are not menopausal or have not been surgically sterilized; (10) Patients participating in the study (or their legal representatives) understand and voluntarily sign informed consent, have good compliance, and are willing to cooperate with follow-up.
Who cannot join
- Patients who are unable to provide sufficient fresh samples;
- pregnant and lactating women, female patients with fertility and positive pregnancy tests, or patients of childbearing age who are unwilling to take effective contraceptive measures during the whole test period;
- The patient has uncontrollable co-morbidity, including but not limited to: symptomatic congestive heart failure, unstable angina pectoris and myocardial infarction, uncontrolled grade III hypertension, liver insufficiency, renal insufficiency, diabetes uncontrolled blood sugar, arrhythmia and mental illness;
- Other circumstances in which the investigator determines that participation in the study is not appropriate.
Trial locations and contacts
1 site in 1 country.
Hua Li, Ph.D contact
China1 site, 1 recruiting
- Recruiting
Bei Jing Chao-Yang Hospital
Beijing, Beijing Municipality, 100025
Hua Li, Ph.D, +86 010 85231831
About this study
Official title: The PTC Microtumor Model is Used to Guide the Feasibility Study of Treatment for Patients With Drug-resistant or Relapsed Advanced Ovarian Epithelial Cancer or Endometrial Cancer
The clinical treatment of patients with resistant/relapsed/advanced gynecological malignancies is very difficult, and the difficulty lies in the selection of effective drugs. This study was a cohort study of recurrent/drug-resistant advanced ovarian high-grade serous carcinoma and advanced/recurrent endometrial adenocarcinoma treated in our hospital. A total of 20 cases were included in the proposed study group, including 12 cases of high-grade serous ovarian carcinoma and 8 cases of endometrial adenocarcinoma. Twenty patients who did not use PTC model to guide treatment at the same period were selected as controls. To compare the consistency of in vitro drug sensitivity detection results of PTC microtumor with clinical therapeutic effect, and to explore the feasibility of using PTC microtumor model to guide the treatment of patients with drug-resistant/recurrent advanced ovarian epithelial cancer or endometrial cancer. The clinical therapeutic effects of the study group and the control group were compared, and the rates of CR, PR, SD, PFS, OS and TTP were evaluated by RECIST1.1 standard. PTC models based on different clinical samples (tissue and ascites) were compared to analyze the consistency of in vitro drug sensitivity detection results and the relationship with clinical efficacy.
- Conditions
- Personalized Cancer Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | The results of PTC microtumor model were used to guide treatment, including 12 cases of ovarian cancer and 8 cases of endometrial cancer. | |
| control group | Patients who did not use the PTC model to guide treatment during the same period included 12 cases of ovarian cancer and 8 cases of endometrial cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor remission status
According to RECIST v1.1 criteria, patients were evaluated for tumor remission status (complete response (CR), partial response (PR), stable disease (PR), etc.). SD) or progressive disease (PD).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Sep 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personalized Cancer TreatmentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hua Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hua Li, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232213
- Sponsor's protocol ID
- LH2401
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PTC Microtumor Model is Used to Guide the Feasibility Study of Treatment for Patients With Drug-resistant or Relapsed Advanced Ovarian Epithelial Cancer or Endometrial Cancer
- ClinicalTrials.gov ID
- NCT06232213
- Acronym / sponsor ID
- LH2401
- Conditions
- Personalized Cancer Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hua LiUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 30 Jan 2024 (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.
The clinical treatment of patients with resistant/relapsed/advanced gynecological malignancies is very difficult, and the difficulty lies in the selection of effective drugs. This study was a cohort study of recurrent/drug-resistant advanced ovarian high-grade serous carcinoma and advanced/recurrent endometrial adenocarcinoma treated in our hospital. A total of 20 cases were included in the proposed study group, including 12 cases of high-grade serous ovarian carcinoma and 8 cases of endometrial adenocarcinoma. Twenty patients who did not use PTC model to guide treatment at the same period were selected as controls. To compare the consistency of in vitro drug sensitivity detection results of PTC microtumor with clinical therapeutic effect, and to explore the feasibility of using PTC microtumor model to guide the treatment of patients with drug-resistant/recurrent advanced ovarian epithelial cancer or endometrial cancer. The clinical therapeutic effects of the study group and the control group were compared, and the rates of CR, PR, SD, PFS, OS and TTP were evaluated by RECIST1.1 standard. PTC models based on different clinical samples (tissue and ascites) were compared to analyze the consistency of in vitro drug sensitivity detection results and the relationship with clinical efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | –The results of PTC microtumor model were used to guide treatment, including 12 cases of ovarian cancer and 8 cases of endometrial cancer. |
| control group | – | –Patients who did not use the PTC model to guide treatment during the same period included 12 cases of ovarian cancer and 8 cases of endometrial cancer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recurrent/drug-resistant and advanced ovarian high-grade serous carcinoma and advanced/recurrent endometrial adenocarcinoma were treated at Beijing Chaoyang Hospital.
Key inclusion criteria (11 listed)
- Age ≥18 years, ≤80 years
- Recurrent/drug-resistant gynecological tumors include: ① patients with advanced high-grade ovarian serous cancer whose tumor is uncontrolled or recurrent within 6 months after receiving platinum-based chemotherapy; ② Advanced ovarian high-grade serous cancer patients with platinum resistance at first treatment; ③ Patients with advanced or recurrent endometrial adenocarcinoma.
- Life expectancy > 6 months;
- Malignant tumors that are not being treated by other systems or are in an active phase;
- Have at least one measurable target lesion according to RECIST1.1 criteria;
Key exclusion criteria (4 listed)
- Patients who are unable to provide sufficient fresh samples;
- pregnant and lactating women, female patients with fertility and positive pregnancy tests, or patients of childbearing age who are unwilling to take effective contraceptive measures during the whole test period;
- The patient has uncontrollable co-morbidity, including but not limited to: symptomatic congestive heart failure, unstable angina pectoris and myocardial infarction, uncontrolled grade III hypertension, liver insufficiency, renal insufficiency, diabetes uncontrolled blood sugar, arrhythmia and mental illness;
- Other circumstances in which the investigator determines that participation in the study is not appropriate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
tumor remission status
Time frame: 24 months
According to RECIST v1.1 criteria, patients were evaluated for tumor remission status (complete response (CR), partial response (PR), stable disease (PR), etc.). SD) or progressive disease (PD).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Hua Li, Ph.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Personalized Cancer Treatment, run by Hua Li 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 11 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Jan 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guangming Cao, Ph.D (+86 13240104755, caoguangming_2009@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor remission status (time frame: 24 months). 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 30 Jan 2024.