PTC in Personalizing Neoadjuvant Therapy for Patients With Advanced Gastrointestinal Tumor

Gastrointestinal Neoplasms Clinical Trial

Official title:

Patient-derived Tumor-like Cell Clusters (PTC) in Personalizing Neoadjuvant Therapy for Patients With Advanced Gastrointestinal Tumor: A Prospective, Open-label and Randomized Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05280210
• Other study ID #: PKUCH-PTC
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2022
• Source: Peking University
• Contact: Aiwen Wu, M.D.
• Phone: +8613911577190
• Email: wuaw[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 420
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological complete response rate(pCR)	having no invasive cancer left in the resected sample	immediately evaluated after surgery
Secondary	pathological response rate	tumor regression grade 0-2	immediately evaluated after surgery
Secondary	objective response rate(ORR)	CR+PR according to RECIST 1.1	evaluated by imaging before surgery
Secondary	disease control rate(DCR)	CR+PR+SD according to RECIST 1.1	evaluated by imaging before surgery
Secondary	R0 resection rate	microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed	immediately evaluated after surgery
Secondary	prediction accuracy of PTC	consistency between the effect of neoadjuvant chemotherapy and the result of PTC assay	immediately evaluated after surgery