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Study of Sirolimus in Patients With Advanced Pancreatic Cancer

NCT03662412 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-09-07

No results posted yet for this study

Summary

Pancreatic cancer is a highly malignant tumor of the digestive system.In China, the annual mortality/morbidity of pancreatic cancer is as high as 0.88:1, and the morbidity and mortality are still on the rise. The 5-year survival rate of pancreatic cancer patients in the United States is only 8%, among which more than 50% of patients have distant metastasis at the time of diagnosis, and the 5-year survival rate of advanced patients with distant metastasis is as low as 3%, with extremely poor prognosis. Currently there is no standard treatment for the first - and second-line treatment resistant and postoperative recurrent patients to further prolong their survival.

mammilian target of rapamycin (mTOR) is a very important serine/threonine protein kinase involved in the regulation of energy metabolism, cell growth, angiogenesis and other cellular biological processes.Rapamycin (sirolimus) is a selective inhibitor of mTOR kinase, which can inhibit the activation and proliferation of T lymphocytes to inhibit the immune response.Currently, mTOR inhibitors are also widely used in tumor treatment. Several studies have been performed to evaluate the efficacy of sirolimus in some solid tumors, and encouraging results are obtained. However, the existing studies on mTOR inhibitors and pancreatic cancer treatment are mostly phase I trials, with little evaluation of the efficacy. Therefore, the phase II clinical trial of rapamycin in the treatment of pancreatic cancer is very necessary.

In preclinical studies, investigators found that rapamycin can effectively inhibit the angiogenesis of liver Cancer led by tumor-associated macrophages (TAM), thereby inhibiting the progression of liver Cancer.In vitro experiments on pancreatic cancer showed that rapamycin can directly inhibit the proliferation of pancreatic cancer cells.After the treatment with rapamycin in the homologous xenograft tumor model of mice, it was found that the tumor growth of mice was significantly inhibited. Further analysis suggested that rapamycin not only directly inhibits tumor proliferation, but also reverses the immune suppressive microenvironment of pancreatic cancer and promotes the T-cell-mediated anti-tumor immune response.Preclinical findings suggest that rapamycin may benefit survival in pancreatic cancer patients, which makes us very interested in the efficacy of rapamycin in patients with advanced pancreatic cancer.Therefore, investigators designed this trial to evaluate the clinical efficacy of rapamycin in patients with second-line resistance and recurrence who lacked a standard treatment regimen.

Conditions

Interventions

DRUG

Sirolimus

Oral solution of sirolimus, 2mg, once a day.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Tingbo Liang, MD Ph.D · second affiliated hospital, Zhejiang University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03662412 on ClinicalTrials.gov