PTC Drug Sensitivity Detection to Guide Postoperative Adjuvant of Colorectal Cancer

NCT05978349 | Unknown DMC

• 1 other identifier: 2022-PUMCH-B-005
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The research objectives is to compare vitro 3D drug sensitivity test results of micro tumor (PTC) with the clinical outcomes of patients, evaluate the consistency between the test results of the technology platform and the clinical prognosis, and explore the decision-making value and guiding significance of this technology in assisting the precise treatment of colorectal cancer. The completion of this study will provide real-world data support for the clinical application of micro tumor (PTC) in vitro 3D drug sensitivity detection technology, and provide more valuable reference basis for realizing the individualization and accuracy of colorectal cancer treatment and improving the clinical benefit rate.

Conditions

Colo-rectal Cancer

Keywords

colon cancer; rectal cancer; adjuvant therapy; PTC

Outcome Measures

Primary Outcomes (1)

• Follow-up and record DFS of patients

  We follow-up the patients by outpatient/telephone/online message to find out their survival situation and record their Disease-free-survival time

  3 years after enrollment

Secondary Outcomes (5)

• Follow-up and record TTP of patients

  3 years after enrollment

• Consistency between drug sensitivity results and clinical outcomes

  3 years after enrollment

• Follow-up and record ORR of patients

  3 years after enrollment

• Follow-up and record PFS of patients

  3 years after enrollment

• Follow-up and record OS of patients

  3 years after enrollment

Study Arms (2)

experimental group

EXPERIMENTAL

Select adjuvant chemotherapy scheme according to 3D drug sensitivity test results of micro tumor (PTC) in vitro

Drug: adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro

control group

NO INTERVENTION

Formulate adjuvant chemotherapy strategy based on clinical experience

Interventions

adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro DRUG

Choose chemotherapeutic drugs（5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate） based on PTC drug sensitivity results.

Also known as: PTC drug sensitivity results

experimental group

Eligibility Criteria

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

You may qualify if:

• Age 18 \~ 75 years old, regardless of gender
• Patients with colorectal cancer diagnosed by histopathology or cytology
• Colorectal cancer patients who need adjuvant therapy after radical surgery and have not received neoadjuvant therapy
• Having at least one assessable tumor focus
• ECoG physical condition score ≤ 2 points
• Voluntarily participate and sign informed consent

You may not qualify if:

• Patients diagnosed with metastasis
• Patients who cannot obtain tumor samples
• Pregnant and lactating women
• Patients with poor compliance
• Patients with severe cardiovascular and cerebrovascular complications who cannot receive adjuvant treatment
• Patients with other malignant tumors
• Suffering from serious mental and nervous system diseases
• The researchers believe that patients should not be selected for this study

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Beijing, China/Beijing, 100000, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

In Vitro Techniques

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Guo Lin, Professor

  PUMCH

  STUDY CHAIR

Central Study Contacts

Jiaolin Zhou, Professor

CONTACT

13910136704; conniezhjl@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 7, 2023
• Study Start: February 14, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: August 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)