Radiation EnteritisPhase 2NCT06617182
Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury.
A Phase 2 study testing Thalidomide, Glutamine and Thalidomide+Glutamine in people with Radiation Enteritis, run by Yongquan Shi at 1 site in China.
Trial summary
At present, there is still a lack of standard and effective treatment strategies and procedures for radiation intestinal injury. Studies have shown that thalidomide can effectively treat refractory gastrointestinal bleeding caused by vascular malformation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiation Enteritis
- What is being tested?
- Thalidomide, Glutamine and Thalidomide+Glutamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2024to 1 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years old, gender is not limited;
- Patients with hematochezia symptoms of chronic radiation intestinal injury: Due to the lack of diagnostic gold standard for radiation intestinal injury, a comprehensive analysis of clinical, endoscopic, imaging and histopathological findings was mainly performed to make the diagnosis of radiation intestinal injury on the basis of excluding infectious and other non-infectious intestinal injuries. Exposure to radioactive sources is a necessary factor in the diagnosis of radiation intestinal injury, and tumor activity or recurrence should be excluded.
- The proportion of dominant defecation bleeding in total defecation times in the week before treatment is not less than 20%;
- ECOG score: 0-2.
Who cannot join
- Patients with hemodynamic instability;
- Patients with obvious liver and kidney function injury: bilirubin, aminotransferase (ALT, AST) exceeded the upper limit of normal by 2 times; eGFR<60ml/min or dialysis patients;
- Patients allergic to thalidomide or glutamine;
- Patients whose primary disease was gastrointestinal malignancy;
- Patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.;
- Female patients during pregnancy and breastfeeding (including patients with reproductive needs);
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- Patients infected with HIV;
- Patients who cannot cooperate with regular follow-up and review of laboratory indicators;
- any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, National Clinical Research Center for Digestive Diseases, Department of Gastroenterology & Hepatology, Xijing Hospital, The Fourth Military Medical University, Xi'an, Ch
Xi'an, Shaanxi, 710005
Yongquan Shi Prof.Shi, Dr, 02984771535, von15991351319@163.com
About this study
Official title: Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury: a Single-center, Open-label, Randomized Controlled Study
At present, there is still a lack of standard and effective treatment strategies and procedures for radiation intestinal injury. Studies have shown that thalidomide can effectively treat refractory gastrointestinal bleeding caused by vascular malformation. Therefore, The investigators designed a single-center, open-label, randomized controlled study to evaluate the efficacy and safety of thalidomide combined with glutamine in the treatment of radiation intestinal injury.
Read the detailed description
Screening: This phase will not last longer than one week, and the subject will be assessed for eligibility after signing the informed consent form.
Treatment: Subjects were randomly assigned to three different treatment groups for 8 weeks.
Follow-up: The subjects' defecation status was recorded every day during treatment, telephone follow-up was conducted every two weeks, and laboratory indicators (including blood routine, stool routine, etc.) were tested every four weeks. The test was terminated one week after treatment and the improvement of subjects' stool blood was assessed.
- Conditions
- Radiation Enteritis
- Being tested
- Thalidomide, Glutamine, Thalidomide+Glutamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Patients in thalidomide group took thalidomide orally at a dose of 100mg once a day for 8 weeks.
GlutamineDrug
Also called Compound glutamine enteric-coated capsules
In the glutamine group, two capsules of glutamine were taken orally 3 times a day for 8 weeks.
Thalidomide+GlutamineDrug
Patients in thalidomide combined with glutamine group took thalidomide orally at a dose of 100mg once a day and two capsules of glutamine were taken orally 3 times a day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| The thalidomide group | Experimental | Patients in the thalidomide group will receive oral thalidomide at a dosage of 100 mg one time daily for 8 weeks. Receives: Drug: Thalidomide |
| The glutamine group | Experimental | Patients in the glutamine group were given two enteric-soluble capsules of compound glutamine three times a day for 8 weeks. Receives: Drug: Glutamine |
| The thalidomide combined with glutamine group | Experimental | Patients in the thalidomide combined with glutamine group will receive oral thalidomide at a dosage of 100 mg one time daily and two enteric-soluble capsules of compound glutamine three times a day for 8 weeks. Receives: Drug: Thalidomide+Glutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response rate.
The proportion of overt defecation bleeding in total defecation within 1 week after treatment was reduced by ≥50% compared with 1 week before treatment.
Measured: From enrollment to the end of treatment at 8 weeks.
Secondary outcomes (7)
No further bleeding occurred within 1 week after treatment
Stool occult blood negative 2 times in a row on different dates
Measured: From enrollment to the end of treatment at 8 weeks.
Number of blood transfusions during the treatment period
times
Measured: From enrollment to the end of treatment at 8 weeks.
Red blood cell input
Input red blood cells according to the situation
Measured: From enrollment to the end of treatment at 8 weeks.
Hemoglobin level
Record each test result
Measured: From enrollment to the end of treatment at 8 weeks.
Number of hospitalizations due to bleeding
times
Measured: From enrollment to the end of treatment at 8 weeks.
Number of days in hospital due to bleeding
days
Measured: From enrollment to the end of treatment at 8 weeks.
Require surgery
yes or no
Measured: From enrollment to the end of treatment at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start30 Sep 2024
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation EnteritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongquan Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617182
- Sponsor's protocol ID
- KY20242229-F-1
- Status last verified
- Mar 2026
- First submitted
- 25 Sep 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury: a Single-center, Open-label, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06617182
- Acronym / sponsor ID
- KY20242229-F-1
- Conditions
- Radiation Enteritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yongquan ShiUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 27 Sep 2024 (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.
At present, there is still a lack of standard and effective treatment strategies and procedures for radiation intestinal injury. Studies have shown that thalidomide can effectively treat refractory gastrointestinal bleeding caused by vascular malformation. Therefore, The investigators designed a single-center, open-label, randomized controlled study to evaluate the efficacy and safety of thalidomide combined with glutamine in the treatment of radiation intestinal injury.
Detailed description
Screening: This phase will not last longer than one week, and the subject will be assessed for eligibility after signing the informed consent form.
Treatment: Subjects were randomly assigned to three different treatment groups for 8 weeks.
Follow-up: The subjects' defecation status was recorded every day during treatment, telephone follow-up was conducted every two weeks, and laboratory indicators (including blood routine, stool routine, etc.) were tested every four weeks. The test was terminated one week after treatment and the improvement of subjects' stool blood was assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The thalidomide group | Experimental | Drug: ThalidomidePatients in the thalidomide group will receive oral thalidomide at a dosage of 100 mg one time daily for 8 weeks. |
| The glutamine group | Experimental | Drug: GlutaminePatients in the glutamine group were given two enteric-soluble capsules of compound glutamine three times a day for 8 weeks. |
| The thalidomide combined with glutamine group | Experimental | Drug: Thalidomide+GlutaminePatients in the thalidomide combined with glutamine group will receive oral thalidomide at a dosage of 100 mg one time daily and two enteric-soluble capsules of compound glutamine three times a day for 8 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years old, gender is not limited;
- Patients with hematochezia symptoms of chronic radiation intestinal injury: Due to the lack of diagnostic gold standard for radiation intestinal injury, a comprehensive analysis of clinical, endoscopic, imaging and histopathological findings was mainly performed to make the diagnosis of radiation intestinal injury on the basis of excluding infectious and other non-infectious intestinal injuries. Exposure to radioactive sources is a necessary factor in the diagnosis of radiation intestinal injury, and tumor activity or recurrence should be excluded.
- The proportion of dominant defecation bleeding in total defecation times in the week before treatment is not less than 20%;
- ECOG score: 0-2.
Key exclusion criteria (9 listed)
- Patients with hemodynamic instability;
- Patients with obvious liver and kidney function injury: bilirubin, aminotransferase (ALT, AST) exceeded the upper limit of normal by 2 times; eGFR<60ml/min or dialysis patients;
- Patients allergic to thalidomide or glutamine;
- Patients whose primary disease was gastrointestinal malignancy;
- Patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.;
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 |
|---|---|---|
| ThalidomidePatients in thalidomide group took thalidomide orally at a dose of 100mg once a day for 8 weeks. | Drug | The thalidomide group |
| GlutamineAlso: Compound glutamine enteric-coated capsulesIn the glutamine group, two capsules of glutamine were taken orally 3 times a day for 8 weeks. | Drug | The glutamine group |
| Thalidomide+GlutaminePatients in thalidomide combined with glutamine group took thalidomide orally at a dose of 100mg once a day and two capsules of glutamine were taken orally 3 times a day for 8 weeks. | Drug | The thalidomide combined with glutamine group |
Primary outcome
Treatment response rate.
Time frame: From enrollment to the end of treatment at 8 weeks.
The proportion of overt defecation bleeding in total defecation within 1 week after treatment was reduced by ≥50% compared with 1 week before treatment.
7 secondary outcomes
No further bleeding occurred within 1 week after treatment
Time frame: From enrollment to the end of treatment at 8 weeks.
Number of blood transfusions during the treatment period
Time frame: From enrollment to the end of treatment at 8 weeks.
Red blood cell input
Time frame: From enrollment to the end of treatment at 8 weeks.
Hemoglobin level
Time frame: From enrollment to the end of treatment at 8 weeks.
Number of hospitalizations due to bleeding
Time frame: From enrollment to the end of treatment at 8 weeks.
Number of days in hospital due to bleeding
Time frame: From enrollment to the end of treatment at 8 weeks.
Require surgery
Time frame: From enrollment to the end of treatment at 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide, Glutamine and Thalidomide+Glutamine in people with Radiation Enteritis, run by Yongquan Shi 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongquan Shi (0086 + 02984771515, shiyquan@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response rate. (time frame: From enrollment to the end of treatment at 8 weeks.). 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 27 Mar 2026.