Gastrointestinal TumorsPhase 3NCT06085365
Effects of Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors
A Phase 3 study testing Immunonutrition （Su yusu) and fluorouracil based chemotherapy regimens in people with Gastrointestinal Tumors and Immunonutrition, run by China Medical University, China at 1 site in China.
Trial 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 adverse reactions (including bone marrow suppression, nausea and vomiting, diarrhea, and mucositis) in patients after… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Tumors, Immunonutrition, Postoperative Adjuvant Chemotherapy
- What is being tested?
- Immunonutrition （Su yusu) and fluorouracil based chemotherapy regimens
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2023to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110000
Xiujuan Qu, Doctor, 13604031355, cmu1h_zlnk_trial@163.com
About this study
Official title: A Multicenter, Open-label, Parallel Controlled, Prospective Cohort Study Evaluating Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors
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 adverse reactions (including bone marrow suppression, nausea and vomiting, diarrhea, and mucositis) in patients after two cycles of chemotherapy. The secondary endpoint indicators were: quality of life score (EORTC-QLQ-C30), nutritional risk score (PG-SGA, NRS2002), nutritional assessment indicators, changes in immune microenvironment, analysis of psychological status, survival time (1-year progression free survival rate), treatment tolerance (dose intensity, rate of treatment interruption, delay), etc.
- Being tested
- Immunonutrition （Su yusu), fluorouracil based chemotherapy regimens
- Medical subject headings
- Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunonutrition （Su yusu)Drug
Immunonutrition （Su yusu） 250ml oral twice a day d1-d21
fluorouracil based chemotherapy regimensDrug
fluorouracil based chemotherapy regimens
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | normal diet group Receives: Drug: fluorouracil based chemotherapy regimens |
| Immunonutrition Group | Experimental | Immunonutrition (Suyusu) 250ml oral twice one day d1-d21 for two cycles Receives: Drug: Immunonutrition （Su yusu); Drug: fluorouracil based chemotherapy regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of chemotherapy related adverse reactions
including bone marrow suppression, nausea and vomiting, diarrhea, and mucositis and so on.
Measured: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
Secondary outcomes (6)
quality of life score
EORTC(The European Organization for Reasearch and Treatment of Cancer)-QOL-C30 (Quality of Life Questionnare-Core 30), patients need to answer all the questions by circling the number (1,2,3,4), big number means the worse quality of life score
Measured: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
nutritional risk score
(PG-SGA) the patient-generated subjective global assessment. The result (A means well-nourished, B means middling-cacotrophia, C means severe malnutrition). Nutritional risk Screening Form 2002 (NRS2002), score ≥3 means patients with nutritional risk, score <3 patients with no nutritional risk. We use the two methods to evaluate the nutritional risk score.
Measured: the first two cycles of chemotherapy. (each cycle is 21 days)
changes in immune microenvironment
cytokines (pg/ml)
Measured: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
survival time
1-year progression free survival rate
Measured: 1-year
treatment tolerance
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
changes in immune microenvironment
Intestinal flora changes
Measured: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start24 Jul 2023
- Primary completion24 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunpeng Liu, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085365
- Sponsor's protocol ID
- CLOG2301
- Status last verified
- Oct 2023
- First submitted
- 30 Sep 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Parallel Controlled, Prospective Cohort Study Evaluating Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT06085365
- Acronym / sponsor ID
- CLOG2301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 24 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 adverse reactions (including bone marrow suppression, nausea and vomiting, diarrhea, and mucositis) in patients after two cycles of chemotherapy. The secondary endpoint indicators were: quality of life score (EORTC-QLQ-C30), nutritional risk score (PG-SGA, NRS2002), nutritional assessment indicators, changes in immune microenvironment, analysis of psychological status, survival time (1-year progression free survival rate), treatment tolerance (dose intensity, rate of treatment interruption, delay), etc.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: fluorouracil based chemotherapy regimensnormal diet group |
| Immunonutrition Group | Experimental | Drug: Immunonutrition （Su yusu), Drug: fluorouracil based chemotherapy regimensImmunonutrition (Suyusu) 250ml oral twice one day d1-d21 for two cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunonutrition （Su yusu)Immunonutrition （Su yusu） 250ml oral twice a day d1-d21 | Drug | Immunonutrition Group |
| fluorouracil based chemotherapy regimensfluorouracil based chemotherapy regimens | Drug | Immunonutrition Group, Placebo Group |
Primary outcome
the incidence of chemotherapy related adverse reactions
Time frame: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
including bone marrow suppression, nausea and vomiting, diarrhea, and mucositis and so on.
6 secondary outcomes
quality of life score
Time frame: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
nutritional risk score
Time frame: the first two cycles of chemotherapy. (each cycle is 21 days)
changes in immune microenvironment
Time frame: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
survival time
Time frame: 1-year
treatment tolerance
Time frame: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
changes in immune microenvironment
Time frame: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
Related trials for Gastrointestinal Tumors
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immunonutrition （Su yusu) and fluorouracil based chemotherapy regimens in people with Gastrointestinal Tumors and Immunonutrition, run by China Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiujuan Qu (86-24-83282312, xiujuanqu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of chemotherapy related adverse reactions (time frame: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.