Status:
UNKNOWN
Effects of Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors
Lead Sponsor:
China Medical University, China
Conditions:
Gastrointestinal Tumors
Immunonutrition
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Evaluate the effects of Suyusu (immunonutrition) in postoperative adjuvant chemotherapy for gastrointestinal cancer patients. The main endpoint of the study was the incidence of chemotherapy related a...
Eligibility Criteria
Inclusion
- Subjects voluntarily and sign an informed consent form;
- Age ≥ 18 years old and ≤ 75 years old;
- Patients with stage II-III gastrointestinal malignancies with clear pathological diagnosis and undergoing radical surgery
- No adjuvant chemotherapy received after surgery
- The Eastern Cancer Collaborative Group's Physical State Score (ECOG) is 0-2 points;
- No contraindications to chemotherapy and the use of fluorouracil based chemotherapy regimens;
Exclusion
- Allergy to the components of immune nutrients, allergic constitution, or other inability to eat;
- Participated in other drug or food clinical trials within 2 months prior to enrollment;
- Having a history of immune deficiency, including HIV testing positive, or having other acquired or congenital immune deficiency diseases, or having a history of organ transplantation, or active infections that are not suitable for chemotherapy (as determined by the researcher);
- Subjects cannot guarantee compliance after participating in the study;
- Other researchers believe that it is not suitable for enrollment.
Key Trial Info
Start Date :
July 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT06085365
Start Date
July 24 2023
End Date
December 31 2024
Last Update
October 16 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110000