PTC in Personalizing Neoadjuvant Therapy for Patients With Advanced Gastrointestinal Tumor

NCT ID: NCT05280210

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-12-31

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.

Conditions

Gastrointestinal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PTC drug screening

Intervention Type: 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.

Neoadjuvant therapy based on clinical experience

Patients will receive neoadjuvant therapy based on clinical experience. The regimen is complied with NCCN and CSCO guidelines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PTC 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Jiafu Ji

Head of Beijing Cancer Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aiwen Wu, M.D.

Role: STUDY_DIRECTOR

Peking University Cancer Hospital & Institute

Central Contacts

Aiwen Wu, M.D.

Role: CONTACT

wuaw@sina.com

+8613911577190

Other Identifiers

PKUCH-PTC

Identifier Type: -

Identifier Source: org_study_id