PTC in Personalizing Neoadjuvant Therapy for Patients With Advanced Gastrointestinal Tumor

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: Gastrointestinal Neoplasms
• Intervention / Treatment: Other: PTC drug screening

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

• Study Contact: Name: Aiwen Wu, M.D.; Phone Number: +8613911577190; Email: wuaw@sina.com

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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.	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.
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)	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	tumor regression grade 0-2	immediately evaluated after surgery
objective response rate(ORR)	CR+PR according to RECIST 1.1	evaluated by imaging before surgery
disease control rate(DCR)	CR+PR+SD according to RECIST 1.1	evaluated by imaging before surgery
R0 resection rate	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	consistency between the effect of neoadjuvant chemotherapy and the result of PTC assay	immediately evaluated after surgery

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Study Director: Aiwen Wu, M.D., Peking University Cancer Hospital & Institute

Study record dates

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: neoadjuvant; chemotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms
• 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