Pancreatic Cancer Clinical Trial
Official title:
Phase II Study of Sirolimus in Patients With Chemo-resistant, Recurrent or Metastatic Pancreatic Cancer
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.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. patients who have failed second-line chemotherapy: patients who had previously received treatment with gemcitabine-based chemotherapy failed, and received fluorouracil based chemotherapy (such as FOLFIRINOX) and had received or not received radiotherapy and failed treatment. 2. the Eastern Cooperative Oncology Group (ECOG) score is 0-1. 3. subject's informed consent, understanding and willing to cooperate with the test program and sign relevant documents. Exclusion Criteria: 1. patients with other malignant tumors or pancreatic cancer have unclear clinical diagnosis, or there are some retroperitoneal lesions with other unclear properties. 2. complicated with uncontrollable central nervous system metastases or neoplastic meningitis. 3. complicated with serious and uncontrollable internal diseases such as severe diabetes, severe hypertension, serious infection, congestive heart failure, ventricular fibrillation, coronary heart disease with obvious symptoms or myocardial infarction in the past 6 months. 4. patients with significant renal dysfunction (serum creatinine beyond the normal range). 5. patients with significant abnormal liver function ( serum bilirubin > 1.5 times or aspartate transaminase (AST)/aspartate transaminase (ALT) > 2.5 times of the normal upper limit, > 5 times of the normal upper limit if there is liver metastasis). 6. patients with significantly abnormal white blood cell count (WBC) (neutrophils < 1500 / mu or platelet < 100 * 10 ^ 3 L/mu L or hemoglobin < 90 g/L). 7. anesthesia, radiotherapy or systemic chemotherapy were performed within the past 2 weeks. 8. drug maintenance: immunosuppressive drugs, and treatment dose of vitamin K antagonist. 9. HIV patients. 10. others: allergic history of similar drugs, pregnancy or lactation. |
Country | Name | City | State |
---|---|---|---|
China | The second affiliated hospital of Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change of carbohydrate Antigen-199 (CA-199) level | Change of blood CA-199 level | Up to 24 months, from 1 day before the first time treatment until date of first documented progression or date of death from any cause | |
Other | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Adverse effect rates | Up to approximately 24 months | |
Primary | overall survival | The duration of time from patients begin with sirolimus treatment to the time of death or the end of the study. | Up to approximately 24 months | |
Secondary | Response rate | Remission, stable or progression | Assessment performed at 6 months after the first treatment |
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