Status:
UNKNOWN
The Clinical Efficacy of Drug Sensitive Neoadjuvant Chemotherapy Based on Organoid Versus Traditional Neoadjuvant Chemotherapy in Advanced Rectal Cancer
Lead Sponsor:
Shanghai Minimally Invasive Surgery Center
Collaborating Sponsors:
Shanghai OneTar Biomedicine Co., Ltd.
Ruijin Hospital
Conditions:
Neoadjuvant Therapy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a prospective multicenter randomized controlled trial study. According to the enrollment criteria, patients with locally advanced rectal cancer who need neoadjuvant therapy before radical surg...
Detailed Description
Based on the need for individualized treatment in the era of precision medicine, an in vitro model that can accurately predict the response of patients to treatment is urgently needed, so that suitabl...
Eligibility Criteria
Inclusion
- 1\) Age: 18-75. 2) qualitative diagnosis: adenocarcinoma was confirmed by enteroscopic biopsy. 3) Localization diagnosis: the tumor is located in the rectum (the distance between the tumor and the anal margin ≤ 12cm).
- 4\) plain scan of thoracoabdominal pelvis and enhanced CT or MRI evaluation of rectal cancer staging:
- The primary tumor invades the muscular layer of the intestinal wall into the surrounding well-known structure, with or without lymph node metastasis in the proper rectal fascia.
- b. TNM clinical or pathological stage of tumor: T3-T4N0-2M0. 5) physical condition (ECOG) score ≤ 1. 6) all patients agreed to receive adjuvant chemotherapy for 3 to 6 months after operation.
- 7\) sign informed consent and participate in the project voluntarily.
Exclusion
- 1\) simultaneous or metachronous multiple primary malignant tumors. 2) preoperative imaging examination or pathological results showed that:
- Lateral lymph node metastasis. b. Distant organ metastasis. 3) previous history of malignant tumors. 4) abnormal function of heart, lung, liver, kidney, hematopoiesis and bone marrow reserve, which can not tolerate neoadjuvant therapy and operation.
- 5\) have mental illness or other serious cardiovascular disease. 6) pregnant or lactating women. 7) Emergency surgery (perforation, bleeding, intestinal obstruction, etc.). 8) BRAF mutation was found by gene detection.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT05352165
Start Date
January 1 2023
End Date
December 31 2025
Last Update
April 28 2022
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