PTC in Personalizing Neoadjuvant Therapy for Patients Wit... | NCT05280210

Studies
PTC in Personalizing Neoadjuvant Therapy for Patients With Advanced Gastrointestinal Tumor

NCT05280210

Sponsor

Peking University

Status

Unknown status

Last Update Posted

Mar 15, 2022Actual

Enrollment

420Estimated

Phase

Not Applicable

Conditions

Gastrointestinal Neoplasms

Interventions

PTC drug screening

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2022Estimated

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Mar 4, 2022

First Submission Date that Met QC Criteria

Mar 4, 2022

First Posted Date

Mar 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2022

Last Update Posted Date

Mar 15, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To explore the value of PTC drug screening technique in selecting neoadjuvant therapy for advanced gastrointestinal cancer.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

420Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neoadjuvant therapy based on PTC drug screening	Experimental	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.	Other: PTC drug screening
Neoadjuvant therapy based on clinical experience	No Intervention	Patients will receive neoadjuvant therapy based on clinical experience. The regimen is complied with NCCN and CSCO guidelines.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PTC drug screening	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pathological complete response rate(pCR)	having no invasive cancer left in the resected sample	immediately evaluated after surgery

Secondary Outcomes

Measure	Description	Time Frame
pathological response rate	tumor regression grade 0-2	immediately evaluated after surgery
objective response rate(ORR)	CR+PR according to RECIST 1.1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Aiwen Wu, M.D.	Contact	+8613911577190		wuaw@sina.com

Name	Affiliation	Role
Aiwen Wu, M.D.	Peking University Cancer Hospital & Institute	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D005770	Gastrointestinal Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided