Clinical trial NCT05280210: PTC in Personalizing Neoadjuvant Therapy for Patients With Advanced Gastrointestinal Tumor
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Neoplasms
Keywords: neoadjuvant
chemotherapy
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: pathological complete response rate(pCR)
timeFrame: immediately evaluated after surgery
Secondary outcomes:
measure: pathological response rate
timeFrame: immediately evaluated after surgery
measure: objective response rate(ORR)
timeFrame: evaluated by imaging before surgery
measure: disease control rate(DCR)
timeFrame: evaluated by imaging before surgery
measure: R0 resection rate
timeFrame: immediately evaluated after surgery
measure: prediction accuracy of PTC
timeFrame: immediately evaluated after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Aiwen Wu, M.D.
role: STUDY_DIRECTOR
References: