PTC in Personalizing Neoadjuvant Therapy for Patients With Advanced Gastrointestinal Tumor
March 4, 2022 updated by: Jiafu Ji, Peking University
Patient-derived Tumor-like Cell Clusters (PTC) in Personalizing Neoadjuvant Therapy for Patients With Advanced Gastrointestinal Tumor: A Prospective, Open-label and Randomized Study
To explore the value of PTC drug screening technique in selecting neoadjuvant therapy for advanced gastrointestinal cancer.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
In this study, patients diagnosed with advanced gastrointestinal cancer including locally advanced gastric cancer, locally advanced colorectal cancer and colorectal cancer with liver metastasis. Tumor sample will be collected by endoscopy biopsy, needle biopsy or surgery, which will used for PTC drug screening.
Patients will be randomized to two groups. Patients in experiment group will receive neoadjuvant therapy based on PTC drug screening, and patients in control group will receive neoadjuvant therapy based on clinical experience. 2-4 cycles of neoadjuvant therapy will be administered. Patients appropriate for surgery will receive radical surgery after neoadjuvant therapy. Pathological response will be compared primarily between these two groups.
This is a randomized controlled, open-label and sequential designed clinical trial. All neoadjuvant therapy used in this study or for PTC drug screening comply with NCCN (National comprehensive cancer network) or CSCO (Chinese Society of Clinical Oncology) guidelines.
Study Type
Interventional
Enrollment (Anticipated)
420
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aiwen Wu, M.D.
- Phone Number: +8613911577190
- Email: wuaw@sina.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosed of gastrointestinal adenocarcinoma by biopsy
- existence of initially resectable lesions evaluated by investigators
- indications of neoadjuvant chemotherapy including: 1) locally advanced gastric cancer cT1-2N1-3M0 & cT3-4N0-3M0; 2) locally advanced colorectal cancer cT3-4 or N+; 3)colorectal carcinoma with synchronous liver metastases: CRS≤2; 4)other patients who are considered to be appropriate to receive neoadjuvant chemotherapy determined by MDT
- never receive any tumor related treatment including chemotherapy, radiotherapy, and immune therapy
- never diagnosed of other malignancies
- able to tolerate chemotherapy
- ECOG≤2
- life expectance >6 months
- at least 1 measurable lesions(according to RECIST 1.1)
- informed consent
Exclusion Criteria:
- pregnant or lactating women
- participating in other clinical trials within 6 months
- MSI-H or dMMR or EBER(+)
- lesion located within 10cm from anal margin
- severe liver dysfunction
- severe renal dysfunction
- cognitive disorder, mental disease or poor compliance
- allergic to known chemotherapeutic agents
- other conditions not suitable to participate in this trial determined by investigators
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Neoadjuvant therapy based on PTC drug screening
Patients will receive neoadjuvant therapy based on PTC drug screening.
The regimen is complied with NCCN and CSCO guidelines.
PD-1 inhibitor will be used if effective in drug screening.
|
PTC is an in vitro tumor model, which serves as a structural and functional unit recapitulating the original tumors in genotype, phenotype, and drug response.
PTC will be used in drug screening.
|
|
No Intervention: Neoadjuvant therapy based on clinical experience
Patients will receive neoadjuvant therapy based on clinical experience.
The regimen is complied with NCCN and CSCO guidelines.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pathological complete response rate(pCR)
Time Frame: immediately evaluated after surgery
|
having no invasive cancer left in the resected sample
|
immediately evaluated after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pathological response rate
Time Frame: immediately evaluated after surgery
|
tumor regression grade 0-2
|
immediately evaluated after surgery
|
|
objective response rate(ORR)
Time Frame: evaluated by imaging before surgery
|
CR+PR according to RECIST 1.1
|
evaluated by imaging before surgery
|
|
disease control rate(DCR)
Time Frame: evaluated by imaging before surgery
|
CR+PR+SD according to RECIST 1.1
|
evaluated by imaging before surgery
|
|
R0 resection rate
Time Frame: immediately evaluated after surgery
|
microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed
|
immediately evaluated after surgery
|
|
prediction accuracy of PTC
Time Frame: immediately evaluated after surgery
|
consistency between the effect of neoadjuvant chemotherapy and the result of PTC assay
|
immediately evaluated after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Aiwen Wu, M.D., Peking University Cancer Hospital & Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2022
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
March 4, 2022
First Submitted That Met QC Criteria
March 4, 2022
First Posted (Actual)
March 15, 2022
Study Record Updates
Last Update Posted (Actual)
March 15, 2022
Last Update Submitted That Met QC Criteria
March 4, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PKUCH-PTC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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