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Preliminary study for the efficacy and safety of Callispheres microspheres in interventional treatment of hepatic metastasis from gastrointestinal and pancreatic neuroendocrine tumors

Preliminary study for the efficacy and safety of polyvinyl alcohol-loaded embolic microspheres in interventional treatment of hepatic metastasis from gastrointestinal and pancreatic neuroendocrine tumors

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021761
Enrollment
Unknown
Registered
2019-03-08
Start date
2019-03-30
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal pancreatic neuroendocrine tumors

Interventions

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Males or females aged 18-75 have a life cycle of more than 3 months; (2) Liver metastasis of gastrointestinal pancreatic neuroendocrine tumors diagnosed according to the Chinese Pathological Diagnostic Standards for Tumors (2017 edition); (3) There is at least one lesion that can be measured: 3 cm 80g/L; Platelet count (PLT) > 60*10^9/L; Leukocyte count (WBC) > 2*10^9/L; Serum albumin (Alb) > 30g/L; Alpha-alanine aminotransferase (ALT) = 3 *ULN; Glutamic-oxaloacetic transaminase (AST) = 3*ULN; Total bilirubin (TBil) = 3 *ULN; Serum creatinine (Cr) = 1.5 *ULN; (8) Female patients are not pregnant, do not breast-feed, apply effective contraceptive measures, agree not to be pregnant within the trial cycle and 12 months thereafter, and male patients agree that their spouses are not pregnant during the trial period and 12 months thereafter; (9) Voluntary treatment and informed consent.

Exclusion criteria

Exclusion criteria: (1) During the experiment, the combination of drugs may affect the evaluation of the observed indicators; (2) Leukocyte < 2.0 *109/L, platelet < 60 *10^9/L; (3) The proportion of tumors in the whole liver is more than 70%; (4) Patients with extensive extrahepatic metastasis of tumors; (5) patients with arteriovenous shunt in tumors; (6) Enhanced CT/MRI showed portal vein trunk, primary branch tumor thrombus or arteriovenous fistula; (7) Patients with severe primary diseases such as cardio-cerebrovascular disease, liver, kidney, hematopoietic system and psychosis; (8) Coagulation dysfunction that cannot be corrected; (9) Patients allergic to iodine products and related accessories; (10) Those who fail to use drugs according to the prescriptions with informed consent can not judge the curative effect, or whose data are incomplete affect the judgment of curative effect; (11) HIV infection or AIDS-related diseases; (12) In the first six months of this study, it was in the treatment stage of other clinical studies; (13) Other medical and psychological conditions that prevent patients from participating in research or signing informed consent.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Objective remission rate;Liver function reserve;adverse event;

Countries

China

Contacts

Public ContactJingyu Liu

Shanghai Changhai Hospital

ljy6259@126.com+86 13524275590

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026