PTC in Personalizing Neoadjuvant Therapy for Patients With Advanced Gastrointestinal Tumor

• Sponsor: Peking University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05280210
• Collaborator: (none)
• Enrollment: 420
• Arms: 2
• Anticipated Duration (Months): 33

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Neoplasms	Other: PTC drug screening	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 420 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• 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
• Anticipated Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. pathological complete response rate(pCR) [immediately evaluated after surgery]

   having no invasive cancer left in the resected sample

Secondary Outcome Measures

1. pathological response rate [immediately evaluated after surgery]

   tumor regression grade 0-2

2. objective response rate(ORR) [evaluated by imaging before surgery]

   CR+PR according to RECIST 1.1

3. disease control rate(DCR) [evaluated by imaging before surgery]

   CR+PR+SD according to RECIST 1.1

4. R0 resection rate [immediately evaluated after surgery]

   microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed

5. prediction accuracy of PTC [immediately evaluated after surgery]

   consistency between the effect of neoadjuvant chemotherapy and the result of PTC assay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Peking University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiafu Ji, Head of Beijing Cancer Hospital, Peking University
• ClinicalTrials.gov Identifier: NCT05280210
• Other Study ID Numbers: PKUCH-PTC
• First Posted: Mar 15, 2022
• Last Update Posted: Mar 15, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jiafu Ji, Head of Beijing Cancer Hospital, Peking University: neoadjuvant; chemotherapy
• Additional relevant MeSH terms: Gastrointestinal Neoplasms; Digestive System Neoplasms

Study Results

No Results Posted as of Mar 15, 2022