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The present study is intended to investigate the objective response rate (ORR) and the progression-free survival (PFS) of the patients with histologically- or cytologically-confirmed metastatic pancreatic cancer after treating with the combination of camrelizumab, gemcitabine and nab-paclitaxel, and to investigate the overall survival (OS) and the adverse event (AE) of the patients with histologically- or cytologically-confirmed metastatic pancreatic cancer after treating with the combination of camrelizumab, gemcitabine and nab-paclitaxel.
This a prospective, single-arm, open-label, phase 2 studye evaluating the efficacy and safety of camrelizumab, gemcitabine and nab-paclitaxel for metastatic pancreatic cancer patients. The primary endpoints are ORR and PFS, and the secondary are OS and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| camrelizumab + nab-paclitaxel + gemcitabine | Experimental | PD-1 Monoclonal Antibody Camrelizumab at 200 mg on Day 1 and 15 nab-paclitaxel at 100 mg/m2 on Day 1, 8, and 15; gemcitabine at 1000 mg/m2 on Day 1, 8, and 15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Patients firstly receive camrelizumab 200 mg per time (iv, no less than 20 minutes and no more than 60 minutes, rinse time included) on Day 1 and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence, unacceptable toxicity, death or begin a novel therapeutic. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | To evaluate the Overall Response Rate of patients with metastatic pancreatic cancer after the treatment of camrelizumab with nab-paclitaxel plus gemcitabine. | from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months |
| Progression Free Survival | To evaluate the Progression Free Survival of patients with metastatic pancreatic cancer after the treatment of camrelizumab with nab-paclitaxel plus gemcitabine. | from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | To evaluate the overall survival of patients with metastatic pancreatic cancer after the treatment of camrelizumab with nab-paclitaxel plus gemcitabine. | from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months |
| adverse events |
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Inclusion Criteria:
1. Signed informed consent form obtained prior to treatment. The patients were fully explained and understood the purpose, contents, predicted efficacy, pharmacological effects, and risks of this study.
2. target patients
Male and female patients at the age of 18-75
Subjects of child-bearing age must agree to take effective contraceptive measures during the study period; Serum or urine pregnancy tests must be negative for women of childbearing age 24 hours before the start of therapy;
Women must not lactate.
Exclusion Criteria:
1. The target disease has cerebral metastasis; 2. Previously treated by anti-PD-1 or anti-PD-L1 drugs; 3. Received any investigational drug within 4 weeks before the first use of the research drug; 4. Enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or an interventional follow-up clinical study; 5. medical history and complications
patients had uncontrolled serious medical condition that the investigator considered may affect the subject's to receive treatment under the study program. For example, patients with severe medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.
patients who are suffering active, known or suspected autoimmune diseases (including but limited to uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilator therapy, etc.). Subjects with hypothyroidism who only need hormone replacement therapy and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) can be enrolled;
Patients who are suffering from active tuberculosis infection: Patients with active pulmonary tuberculosis infection within 1 year before medication should be excluded even if they have been treated; patients with a history of active tuberculosis infection more than 1 year ago should also be excluded unless it is proven that they have received standard anti-TB treatment before;
Patients who have previous interstitial lung disease or (non-infectious) pneumonia and requires oral or intravenous steroid therapy;
Patients who need to receive long-term systemic hormones (dose equivalent to >10mg prednisone/day) or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids can be enrolled;
Patients who have uncontrolled heart disease, such as:
Dementia, changing of mental state or any mental illness which could hinder understanding or informed consent or fill out questionnaires;
History of allergy or hypersensitivity to any therapeutic ingredient;
Combined with other malignant tumors excepted pancreatic cancer within the first 5 years of randomization, excepted well-treated basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical resection, and ductal carcinoma in situ of the breast after radical resection;
Previously received systemic therapy for advanced/metastatic pancreatic cancer;
Subjects who had previously been pathologically diagnosed with squamous cell carcinoma (no organ limitation) and received neoadjuvant/adjuvant therapy with taxa regimen.
Patients who had Grade 2 or above Peripheral neuropathy according to CTCAE Ver. 5.0.
6. Abnormal results of physical examination and laboratory examination
4. Human immunodeficiency virus (HIV)- or hepatitis C virus (HCV) positive patients; 5. Patients who suffer from active infection requiring systemic treatment; 6. Patients need other concomitant anti-tumor drugs; 7. Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period.
8. Other conditions that the investigators considered are not suitable for the enrollment.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xian-Jun Yu | Contact | +86 21 64175590 | wangwenquan@fudanpci.org | |
| Wen-Quan Wang | Contact | wangwenquan@fudanpci.org |
| Name | Affiliation | Role |
|---|---|---|
| Xian-Jun Yu | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D013660 | Taxes |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
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|
| Nab paclitaxel | Drug | Patients secondly receive nab-paclitaxel 100 mg/m2 (iv, at least 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence, unacceptable toxicity, death or begin a novel therapeutic. |
|
|
| Gemcitabine Injection | Drug | At last, patients receive gemcitabine 1000 mg/m2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence, unacceptable toxicity, death or begin a novel therapeutic. |
|
|
To evaluate the adverse events of patients with metastatic pancreatic cancer after the treatment of camrelizumab with nab-paclitaxel plus gemcitabine. |
| from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D003562 |
| Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |