Colo-rectal CancerNCT05978349
PTC Drug Sensitivity Detection to Guide Postoperative Adjuvant of Colorectal Cancer
A study testing adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro in people with Colo-rectal Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The research objectives is to compare vitro 3D drug sensitivity test results of micro tumor (PTC) with the clinical outcomes of patients, evaluate the consistency between the test results of the technology platform and the clinical prognosis, and explore the decision-making value and guiding significance of this… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2022to 30 Sep 2025
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 ~ 75 years old, regardless of gender
- Patients with colorectal cancer diagnosed by histopathology or cytology
- Colorectal cancer patients who need adjuvant therapy after radical surgery and have not received neoadjuvant therapy
- Having at least one assessable tumor focus
- ECoG physical condition score ≤ 2 points
- Voluntarily participate and sign informed consent
Who cannot join
- Patients diagnosed with metastasis
- Patients who cannot obtain tumor samples
- Pregnant and lactating women
- Patients with poor compliance
- Patients with severe cardiovascular and cerebrovascular complications who cannot receive adjuvant treatment
- Patients with other malignant tumors
- Suffering from serious mental and nervous system diseases
- The researchers believe that patients should not be selected for this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Beijing, China/Beijing, 100000
Jiaolin Zhou, MD, 13910136704, conniezhjl@yahoo.com
About this study
Official title: Vitro 3D Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy and Prognosis Judgment of Colorectal Cancer--Prospective Clinical Study
The research objectives is to compare vitro 3D drug sensitivity test results of micro tumor (PTC) with the clinical outcomes of patients, evaluate the consistency between the test results of the technology platform and the clinical prognosis, and explore the decision-making value and guiding significance of this technology in assisting the precise treatment of colorectal cancer. The completion of this study will provide real-world data support for the clinical application of micro tumor (PTC) in vitro 3D drug sensitivity detection technology, and provide more valuable reference basis for realizing the individualization and accuracy of colorectal cancer treatment and improving the clinical benefit rate.
Read the detailed description
The study is a multi agency prospective cohort study in China. The subjects were patients aged 18 ~ 75 years with colorectal cancer diagnosed by histopathology or cytology. They must be colorectal cancer patients who have at least one assessable tumor focus, need adjuvant therapy after radical surgery, and have not received neoadjuvant therapy， ECoG physical condition score ≤ 2 points. And they must be voluntarily participate in and sign informed consent.
The patients were randomly divided into PTC drug sensitivity test group and control group. The PTC drug sensitivity test group selected the adjuvant chemotherapy scheme according to the 3D drug sensitivity test results of micro tumor (PTC) in vitro. The control group made adjuvant chemotherapy strategy according to clinical experience.
The primary endpoint was the non inferiority test, and the 3-year disease-free survival rate was T-C >- Δ
- Conditions
- Colo-rectal Cancer
- Being tested
- adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro
- Keywords
- colon cancer, rectal cancer, adjuvant therapy, PTC
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitroDrug
Also called PTC drug sensitivity results
Choose chemotherapeutic drugs（5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate） based on PTC drug sensitivity results.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Select adjuvant chemotherapy scheme according to 3D drug sensitivity test results of micro tumor (PTC) in vitro Receives: Drug: adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro |
| control group | No intervention | Formulate adjuvant chemotherapy strategy based on clinical experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up and record DFS of patients
We follow-up the patients by outpatient/telephone/online message to find out their survival situation and record their Disease-free-survival time
Measured: 3 years after enrollment
Secondary outcomes (5)
Follow-up and record TTP of patients
We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Time To Progress
Measured: 3 years after enrollment
Consistency between drug sensitivity results and clinical outcomes
Record the patient's PTC drug sensitivity results and the actual medication therapy, and record the patient's survival status through telephone follow-up, online follow-up and offline diagnosis to compare whether there is correlation between them.
Measured: 3 years after enrollment
Follow-up and record ORR of patients
We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Objective Response Rate
Measured: 3 years after enrollment
Follow-up and record PFS of patients
We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Progress Free Survival time
Measured: 3 years after enrollment
Follow-up and record OS of patients
We follow-up the patients by outpatient/telephone/online message to find out their tumor and survival situation and record their Overall Survival time
Measured: 3 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start14 Feb 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guo Lin, Professor, Study chair, PUMCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978349
- Sponsor's protocol ID
- 2022-PUMCH-B-005
- Status last verified
- Jul 2023
- First submitted
- 27 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitro 3D Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy and Prognosis Judgment of Colorectal Cancer--Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT05978349
- Acronym / sponsor ID
- 2022-PUMCH-B-005
- Conditions
- Colo-rectal Cancer
- Keywords
- colon cancer, rectal cancer, adjuvant therapy, PTC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 7 Aug 2023 (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 research objectives is to compare vitro 3D drug sensitivity test results of micro tumor (PTC) with the clinical outcomes of patients, evaluate the consistency between the test results of the technology platform and the clinical prognosis, and explore the decision-making value and guiding significance of this technology in assisting the precise treatment of colorectal cancer. The completion of this study will provide real-world data support for the clinical application of micro tumor (PTC) in vitro 3D drug sensitivity detection technology, and provide more valuable reference basis for realizing the individualization and accuracy of colorectal cancer treatment and improving the clinical benefit rate.
Detailed description
The study is a multi agency prospective cohort study in China. The subjects were patients aged 18 ~ 75 years with colorectal cancer diagnosed by histopathology or cytology. They must be colorectal cancer patients who have at least one assessable tumor focus, need adjuvant therapy after radical surgery, and have not received neoadjuvant therapy， ECoG physical condition score ≤ 2 points. And they must be voluntarily participate in and sign informed consent.
The patients were randomly divided into PTC drug sensitivity test group and control group. The PTC drug sensitivity test group selected the adjuvant chemotherapy scheme according to the 3D drug sensitivity test results of micro tumor (PTC) in vitro. The control group made adjuvant chemotherapy strategy according to clinical experience.
The primary endpoint was the non inferiority test, and the 3-year disease-free survival rate was T-C >- Δ
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitroSelect adjuvant chemotherapy scheme according to 3D drug sensitivity test results of micro tumor (PTC) in vitro |
| control group | No intervention | –Formulate adjuvant chemotherapy strategy based on clinical experience |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 ~ 75 years old, regardless of gender
- Patients with colorectal cancer diagnosed by histopathology or cytology
- Colorectal cancer patients who need adjuvant therapy after radical surgery and have not received neoadjuvant therapy
- Having at least one assessable tumor focus
- ECoG physical condition score ≤ 2 points
Key exclusion criteria (8 listed)
- Patients diagnosed with metastasis
- Patients who cannot obtain tumor samples
- Pregnant and lactating women
- Patients with poor compliance
- Patients with severe cardiovascular and cerebrovascular complications who cannot receive adjuvant treatment
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 |
|---|---|---|
| adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitroAlso: PTC drug sensitivity resultsChoose chemotherapeutic drugs（5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate） based on PTC drug sensitivity results. | Drug | experimental group |
Primary outcome
Follow-up and record DFS of patients
Time frame: 3 years after enrollment
We follow-up the patients by outpatient/telephone/online message to find out their survival situation and record their Disease-free-survival time
5 secondary outcomes
Follow-up and record TTP of patients
Time frame: 3 years after enrollment
Consistency between drug sensitivity results and clinical outcomes
Time frame: 3 years after enrollment
Follow-up and record ORR of patients
Time frame: 3 years after enrollment
Follow-up and record PFS of patients
Time frame: 3 years after enrollment
Follow-up and record OS of patients
Time frame: 3 years after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Colo-rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Guo Lin, Professor study chair
PUMCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro in people with Colo-rectal Cancer, 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 6 inclusion and 8 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 7 Aug 2023. 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 Jiaolin Zhou, Professor (13910136704, conniezhjl@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow-up and record DFS of patients (time frame: 3 years after enrollment). 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 7 Aug 2023.