Pancreatic CancerPhase 1/2NCT03662412
Study of Sirolimus in Patients With Advanced Pancreatic Cancer
A Phase 1/2 study testing Sirolimus in people with Pancreatic Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Sirolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 30 Jun 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- 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.
- the Eastern Cooperative Oncology Group (ECOG) score is 0-1.
- subject's informed consent, understanding and willing to cooperate with the test program and sign relevant documents.
Who cannot join
- patients with other malignant tumors or pancreatic cancer have unclear clinical diagnosis, or there are some retroperitoneal lesions with other unclear properties.
- complicated with uncontrollable central nervous system metastases or neoplastic meningitis.
- 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.
- patients with significant renal dysfunction (serum creatinine beyond the normal range).
- 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).
- 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).
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- anesthesia, radiotherapy or systemic chemotherapy were performed within the past 2 weeks.
- drug maintenance: immunosuppressive drugs, and treatment dose of vitamin K antagonist.
- HIV patients.
- others: allergic history of similar drugs, pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310009
Qi Zhang, MD, 8613819137113
About this study
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.
Read the detailed description
- Research purpose This clinical trial was designed to evaluate the anti-tumor effect of sirolimus in patients with advanced or postoperative recurrent pancreatic cancer with second-line standard therapy resistance.
- Grouping and sample size calculation A single-arm study was designed. Based on clinical experience and literature, the expected median survival period of patients with advanced pancreatic cancer after second-line resistance or postoperative recurrence was about 3 months, and the median survival period of such patients was expected to be extended to 6 months after the treatment with sirolimus. The significance level of statistical test was set at 0.05 and the power of test was set as 80%, the time of enrollment was set to June 2021, and the time of follow-up was set to June 2023. The follow up loss rate was predicted as 5%, and the number of cases needed to be enrolled was calculated as 36.
- Clinical trial procedure For the cases to be included, the patient's medical history, symptoms, signs and other conditions should be examined in advance, informed consent should be obtained and signed, and the patient's age, height, weight, medical history, symptoms, signs, pathological results, tumor node metastasis (TNM) stage and other contents should be recorded.According to the test requirements, the study was designed to be limited to 5 years, and the day of oral administration of sirolimus will be set as the first day, tumor markers will be follow up every 3 weeks.Each 3-month review includes symptoms, signs, adverse events, blood routine examination, liver and kidney function, abdominal enhanced CT, liver enhanced MRI+ diffusion, and chest high-resolution CT. Overall survival (OS) was taken as the primary endpoint and then recorded to the secondary endpoint. All results were recorded in the case report form, clinical efficacy and safety were evaluated, and adverse events were observed.If the patient cannot come to the hospital for reexamination, follow up will be conducted by telephone, email, etc.
- Adverse events record and report Information on non-serious adverse events that occur during treatment should be recorded on the clinical trial report form (CRF), and all serious adverse events will be recorded in the CRF report form.Few patients in this study may have serious liver and kidney function injury, may have allergy reaction, secondary hypertension, hypercholesterolemia, serious infection and so on. In view of the above possible situations, investigators will fully evaluate the liver and kidney function before treatment, and give protective drugs for organ function; And the corresponding adjuvant drugs such as blood pressure drugs, lipid-regulating drugs to prevent sirolimus side effects;The symptoms and indicators of infection were closely monitored. Once adverse events happen, report will be sent to the general manager and the head of the hospital immediately, and also to the ethics committee of adverse events within the specified time, and make unified analysis after the study.
- Data management and statistical analysis Data recording and auditing: The observation data will be recorded by the attending physician in the case report form, and the data records shall be timely, complete, accurate and authentic.The form will be filled out in black (or blue and black), any changes will be made by the relevant personnel, and then signed and dated. The changes will not cover the original record. If possible, copy the relevant test paper and paste it on the attached page after CRF. Data entry: Establish data entry program and database for statistical analysis.
- Informed consent The subject must obtain written informed consent before performing the study procedures to inform the patient of the specific content related to the study. The specific procedures for obtaining informed consent include: the patient's disease characteristics, treatment plan and related risks shall be informed in detail by the competent doctor, and the patient or legal guardian with civil capacity shall sign the informed consent after fully knowing and understanding the relevant process and risks of this study.
- Conditions
- Pancreatic Cancer
- Being tested
- Sirolimus
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called Rapamycin
Oral solution of sirolimus, 2mg, once a day.
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus treatment | Experimental | Oral solution of sirolimus, 2mg, once a day. The trial will be terminated when a serious adverse reaction occurred, or the tumor progressed rapidly twice in a row, or when the patient did not want to continue. Receives: Drug: Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
The duration of time from patients begin with sirolimus treatment to the time of death or the end of the study.
Measured: Up to approximately 24 months
Secondary outcomes (1)
Response rate
Remission, stable or progression
Measured: Assessment performed at 6 months after the first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start1 Jun 2018
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tingbo Liang, MD Ph.D, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662412
- Sponsor's protocol ID
- SAHZU-2018-064
- Status last verified
- Sep 2018
- First submitted
- 20 Aug 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Sirolimus in Patients With Chemo-resistant, Recurrent or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03662412
- Acronym / sponsor ID
- SAHZU-2018-064
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 7 Sep 2018 (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.
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.
Detailed description
- Research purpose This clinical trial was designed to evaluate the anti-tumor effect of sirolimus in patients with advanced or postoperative recurrent pancreatic cancer with second-line standard therapy resistance.
- Grouping and sample size calculation A single-arm study was designed. Based on clinical experience and literature, the expected median survival period of patients with advanced pancreatic cancer after second-line resistance or postoperative recurrence was about 3 months, and the median survival period of such patients was expected to be extended to 6 months after the treatment with sirolimus. The significance level of statistical test was set at 0.05 and the power of test was set as 80%, the time of enrollment was set to June 2021, and the time of follow-up was set to June 2023. The follow up loss rate was predicted as 5%, and the number of cases needed to be enrolled was calculated as 36.
- Clinical trial procedure For the cases to be included, the patient's medical history, symptoms, signs and other conditions should be examined in advance, informed consent should be obtained and signed, and the patient's age, height, weight, medical history, symptoms, signs, pathological results, tumor node metastasis (TNM) stage and other contents should be recorded.According to the test requirements, the study was designed to be limited to 5 years, and the day of oral administration of sirolimus will be set as the first day, tumor markers will be follow up every 3 weeks.Each 3-month review includes symptoms, signs, adverse events, blood routine examination, liver and kidney function, abdominal enhanced CT, liver enhanced MRI+ diffusion, and chest high-resolution CT. Overall survival (OS) was taken as the primary endpoint and then recorded to the secondary endpoint. All results were recorded in the case report form, clinical efficacy and safety were evaluated, and adverse events were observed.If the patient cannot come to the hospital for reexamination, follow up will be conducted by telephone, email, etc.
- Adverse events record and report Information on non-serious adverse events that occur during treatment should be recorded on the clinical trial report form (CRF), and all serious adverse events will be recorded in the CRF report form.Few patients in this study may have serious liver and kidney function injury, may have allergy reaction, secondary hypertension, hypercholesterolemia, serious infection and so on. In view of the above possible situations, investigators will fully evaluate the liver and kidney function before treatment, and give protective drugs for organ function; And the corresponding adjuvant drugs such as blood pressure drugs, lipid-regulating drugs to prevent sirolimus side effects;The symptoms and indicators of infection were closely monitored. Once adverse events happen, report will be sent to the general manager and the head of the hospital immediately, and also to the ethics committee of adverse events within the specified time, and make unified analysis after the study.
- Data management and statistical analysis Data recording and auditing: The observation data will be recorded by the attending physician in the case report form, and the data records shall be timely, complete, accurate and authentic.The form will be filled out in black (or blue and black), any changes will be made by the relevant personnel, and then signed and dated. The changes will not cover the original record. If possible, copy the relevant test paper and paste it on the attached page after CRF. Data entry: Establish data entry program and database for statistical analysis.
- Informed consent The subject must obtain written informed consent before performing the study procedures to inform the patient of the specific content related to the study. The specific procedures for obtaining informed consent include: the patient's disease characteristics, treatment plan and related risks shall be informed in detail by the competent doctor, and the patient or legal guardian with civil capacity shall sign the informed consent after fully knowing and understanding the relevant process and risks of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sirolimus treatment | Experimental | Drug: SirolimusOral solution of sirolimus, 2mg, once a day. The trial will be terminated when a serious adverse reaction occurred, or the tumor progressed rapidly twice in a row, or when the patient did not want to continue. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- the Eastern Cooperative Oncology Group (ECOG) score is 0-1.
- subject's informed consent, understanding and willing to cooperate with the test program and sign relevant documents.
Key exclusion criteria (10 listed)
- patients with other malignant tumors or pancreatic cancer have unclear clinical diagnosis, or there are some retroperitoneal lesions with other unclear properties.
- complicated with uncontrollable central nervous system metastases or neoplastic meningitis.
- 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.
- patients with significant renal dysfunction (serum creatinine beyond the normal range).
- 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).
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 |
|---|---|---|
| SirolimusAlso: RapamycinOral solution of sirolimus, 2mg, once a day. | Drug | Sirolimus treatment |
Primary outcome
overall survival
Time frame: Up to approximately 24 months
The duration of time from patients begin with sirolimus treatment to the time of death or the end of the study.
1 secondary outcome
Response rate
Time frame: Assessment performed at 6 months after the first treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Tingbo Liang, MD Ph.D principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sirolimus in people with Pancreatic Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 7 Sep 2018. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qi Zhang, MD (13819137113, zhangqi86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: Up to approximately 24 months). 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 7 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.