PTC in Personalizing Neoadjuvant Therapy for Patients With Advanced Gastrointestinal Tumor

NCT05280210 | Unknown DMC

• 1 other identifier: PKUCH-PTC
• Study Type: interventional
• Target: 420
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gastrointestinal Neoplasms

Keywords

neoadjuvant; chemotherapy

Outcome Measures

Primary Outcomes (1)

• pathological complete response rate(pCR)

  having no invasive cancer left in the resected sample

  immediately evaluated after surgery

Secondary Outcomes (5)

• pathological response rate

  immediately evaluated after surgery

• objective response rate(ORR)

  evaluated by imaging before surgery

• disease control rate(DCR)

  evaluated by imaging before surgery

• R0 resection rate

  immediately evaluated after surgery

• prediction accuracy of PTC

  immediately evaluated after surgery

Study Arms (2)

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

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.

Neoadjuvant therapy based on PTC drug screening

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Aiwen Wu, M.D.

  Peking University Cancer Hospital & Institute

  STUDY DIRECTOR

Central Study Contacts

Aiwen Wu, M.D.

CONTACT

+8613911577190; wuaw@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Beijing Cancer Hospital

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 15, 2022
• Study Start: April 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: March 15, 2022

Record last verified: 2022-03