Clinical trial NCT06361888: A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Metastatic Pancreatic Cancer
Keywords: First-line treatment in patients
Lead sponsor: Hutchmed
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 482
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of Surufatnib combined withcamrelizumab, 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

Eligibility criteria: 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 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 4 weeks prior to the first dose；
2. Presence of other malignancies in the past 3 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 and CYP2C8 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;

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From date of first dose of study drug until withdrawal of consent or death (up to approximately 20 months)
Secondary outcomes:
measure: Progression-free Survival (PFS) (RECIST1.1)
timeFrame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)
measure: Objective response rate (ORR)(RECIST1.1)
timeFrame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)
measure: Duration of response (DoR)(RECIST1.1)
timeFrame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)
measure: Disease control rate (DCR)(RECIST1.1)
timeFrame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)
measure: Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
timeFrame: From the within 7 days prior to the initiation of treatment to 30 days after the last administration
measure: Cancer Quality of Life Questionnaire - PAN26(EORTC QLQ-PAN26)
timeFrame: From the within 7 days prior to the initiation of treatment to 30 days after the last administration
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Tianyinshan Hospital
state: Jiang Su
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
Study officials:
References: