A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of PD-1 Antibody Camrelizumab in Combination With Nab-paclitaxel Plus Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer
Overview
- Phase
- Phase 2
- Intervention
- Camrelizumab
- Conditions
- Metastatic Pancreatic Cancer
- Sponsor
- Fudan University
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- Overall Response Rate
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Xian-Jun Yu
Vice President
Fudan University
Eligibility Criteria
Inclusion Criteria
- •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.
- •target patients
- •the patients were histopathologically- or cytocologically-confirmed as metastatic pancreatic cancer.
- •At least one measurable objective lesion (both primary and metastatic) was identified based on the RECIST 1.1 criteria;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- •The expected survival after surgery ≥ 3 months
- •The subjects have good compliance, can be treated and followed up, and voluntarily comply with the relevant provisions of this study
- •No contraindications for camrelizumab, gemcitabine and nab-paclitaxel.
- •Age and reproductive status
- •Male and female patients at the age of 18-75
Exclusion Criteria
- •The target disease has cerebral metastasis;
- •Previously treated by anti-PD-1 or anti-PD-L1 drugs;
- •Received any investigational drug within 4 weeks before the first use of the research drug;
- •Enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or an interventional follow-up clinical study;
- •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;
Arms & Interventions
camrelizumab + nab-paclitaxel + gemcitabine
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
Intervention: Camrelizumab
camrelizumab + nab-paclitaxel + gemcitabine
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
Intervention: Nab paclitaxel
camrelizumab + nab-paclitaxel + gemcitabine
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
Intervention: Gemcitabine Injection
Outcomes
Primary Outcomes
Overall Response Rate
Time Frame: from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months
To evaluate the Overall Response Rate of patients with metastatic pancreatic cancer after the treatment of camrelizumab with nab-paclitaxel plus gemcitabine.
Progression Free Survival
Time Frame: from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months
To evaluate the Progression Free Survival of patients with metastatic pancreatic cancer after the treatment of camrelizumab with nab-paclitaxel plus gemcitabine.
Secondary Outcomes
- overall survival(from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months)
- adverse events(from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months)