Metastatic Pancreatic Cancer
Conditions
Keywords
First-line treatment in patients
Brief summary
To evaluate the efficacy of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer
Detailed description
This is a multicenter, randomized, open-label, active-controlled, phase II/III trial to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer
Interventions
DRUGSurufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine
Drug: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine 1. Surufatinib: 200mg, qd 2. Camrelizumab: 200mg, IV drip, Q3W, D1 3. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 4. Gemcitabine : 1000 mg/m2, IV drip, D1, D8
Drug: Nab-paclitaxel Plus Gemcitabine 1. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 2. Gemcitabine : 1000 mg/m2, IV drip, D1, D8
DRUGSurufatinib with Nab-paclitaxel, and Gemcitabine
Drug: Surufatinib with Nab-paclitaxel, and Gemcitabine 1. Surufatinib: 200mg, qd 2. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 3. Gemcitabine : 1000 mg/m2, IV drip, D1, D8
Sponsors
Hutchmed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Fully understand and voluntarily sign an informed consent form, willing and able to follow the study process; 2. Age range is 18-75 years old (inclusive); 3. Pancreatic cancer confirmed by histology or cytology; 4. Stage IV metastasis Pancreatic cancer patients; 5. Have not received previous systematic first line anti-tumor treatment in the stage of metastatic pancreatic cancer; 6. According to RECIST 1.1, there is at least one measurable lesion; 7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1; 8. Expected survival time ≥ 12 weeks;
Exclusion criteria
1. Use of systematic anti-tumor therapy within 2weeks prior to the first dose； 2. Presence of other malignancies in the past 5 years; 3. Received major surgical surgery within 60 days before the first dose; 4. Have received any surgery or invasive treatment within 4 weeks before the first use of the drug; 5. Received palliative radiotherapy within 1 week before the first dose; received radical radiotherapy within 4 weeks before the first dose; 6. Any known allergy to surufatinib or its components, camrelizumab, nab-paclitaxel, or gemcitabine; 7. Received inducers or inhibitors of cytochrome P450 (CYP) 3A within 2 weeks or 5 half-lives (whichever is longer) before the first dose; 8. Use of immunosuppressive drugs within 4 weeks before first dose; 9. Known history of clinically significant liver disease, including active viral hepatitis infection or other active hepatitis or clinically significant moderate to severe cirrhosis; 10. Patients who currently have hypertension that cannot be controlled by medication;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From date of first dose of study drug until withdrawal of consent or death (up to approximately 20 months) | Duration from the date of initial treatment to the date of death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR)(RECIST1.1) | From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months) | The incidence of confirmed complete response or partial response |
| Duration of response (DoR)(RECIST1.1) | From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months) | Duration from the first time reported partial response or complete response to the first time of disease progression or death. |
| Disease control rate (DCR)(RECIST1.1) | From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months) | Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit. |
| Progression-free Survival (PFS) (RECIST1.1) | From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months) | A duration from the date of initial treatment to disease progression or death of any cause. |
| Cancer Quality of Life Questionnaire - PAN26(EORTC QLQ-PAN26)（only for phase III） | From the within 7 days prior to the initiation of treatment to 30 days after the last administration | The changes in health-related quality of life (HRQoL) score from baseline and thehe time to deterioration of symptoms (TTD) as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \- PAN26 (EORTC QLQ-PAN26) |
| Safety and tolerability | From the date of first dose of study drug to 90 days after the last administration | Incidence and nature of treatment emergent adverse events(TEAE), the other safety variables including physical examination, vital signs and laboratory examinations. |
| Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)（only for phase III） | From the within 7 days prior to the initiation of treatment to 30 days after the last administration | The changes in health-related quality of life (HRQoL) score from baseline and the time to deterioration of symptoms (TTD) as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \- Core 30 (EORTC QLQ-C30) |
Countries
China
Contacts
Primary ContactPanfeng Tan
Outcome results
None listed