the Efficiency of Thalidomide for Recurrent Small Intestinal Bleeding Due to Gastrointestinal Vascular Malformation

Inclusion Criteria:

1. Subjects voluntarily signed the informed consent after the nature and the specificprocedures of the trial has been verbally explained; they have the opportunity to askquestions.
2. Chinese nationality;
3. Female or male subjects aged 18-75 years. Female subjects must be menopausal or haveundergone sterilization such as tubal ligation and hysterectomy, or have no plan togive birth recently and agree to take contraceptive measures such as contraceptivedrugs, intrauterine physical birth control rings or contraception condoms; or men musthave undergone sterilization or do not plan to have a child recently and agree to takecontraceptive measures such as contraceptive drugs, or contraception condoms. Thesecriteria are set to eliminate the risk of subjects of child bearing potential.
4. The subjects must have been diagnosed, by capsule endoscopy and / or balloon-assistedenteroscopy, with small intestinal vascular malformation lesions which are unsuitableor inaccessible to endoscopic therapy or surgical antrectomy. Subjects withpersistent, recurrent bleeding, ≥ 4 episodes of overt or occult bleeding over lastyear.

Exclusion Criteria:

1. Subjects with esophageal varices from cirrhosis of the liver; those with uncontrolledhypertension or hyperglycemia (or diabetics who are being treated with insulin), orthose with severe heart (e.g., uncontrolled angina pectoris and / or myocardialinfarction, congestive heart failure, etc.), respiratory failure, or renal failurewith creatinine (Cr) or blood urea nitrogen (BUN) > 2 times the upper limit of normal (ULN), pancreatic or hepatic disease with abnormal hepatic function with alanineaminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin (TBil) > 2times ULN 3 months before the enrollment, or those with any other diseases that arenot suitable for the study as judged by the Investigator;
2. Subjects with a history of severe peripheral neuropathy or seizures, or a history ofthromboembolic disease;
3. Subjects who need to continuously use non-steroidal anti-inflammatory drugs,anticoagulants, antiplatelets, acetylsalicylic acid preparations, or Chinese herbalmedicines containing ginkgo and echinacea; or those who need to receive otheranti-angiogenic drugs for a long time;
4. Subjects with white blood cell counts persistently <3.5 * 10^9 / L;
5. Subjects with a history of small bowel resection;
6. Subjects known or suspected to be allergic to any component of thalidomide；
7. Subjects with severe gastrointestinal bleeding that is life-threatening and requiresimmediate surgical treatment;
8. Subjects who have previously received thalidomide for gastrointestinal bleeding 30days before the enrollment;
9. Alcohol and / or substance abusers with addiction or dependence, or those with poorcompliance as judged by a doctor;
10. Subjects who participated in other clinical trial 6 months before enrollment;
11. Subjects without legal capacity or self-awareness.