Recruiting 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine, Nab-paclitaxel Plus Gemcitabine, Surufatinib with Nab-paclitaxel, and Gemcitabine.
- Who it may be relevant to
- Registry conditions: Metastatic Pancreatic Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Drug Surufatinib 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
Drug: Nab-paclitaxel Plus Gemcitabine 1. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 2. Gemcitabine : 1000 mg/m2, IV drip, D1, D8 - Drug Surufatinib 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
Primary outcome measures
- Overall Survival (OS) [Time frame: From date of first dose of study drug until withdrawal of consent or death (up to approximately 20 months)]
Secondary outcome measures (6)
- Progression-free Survival (PFS) (RECIST1.1) [Time frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)]
- Objective response rate (ORR)(RECIST1.1) [Time frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)]
- Duration of response (DoR)(RECIST1.1) [Time frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)]
- Disease control rate (DCR)(RECIST1.1) [Time frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)]
- Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)（only for phase III） [Time frame: From the within 7 days prior to the initiation of treatment to 30 days after the last administration]
- Cancer Quality of Life Questionnaire - PAN26(EORTC QLQ-PAN26)（only for phase III） [Time frame: From the within 7 days prior to the initiation of treatment to 30 days after the last administration]
Eligibility criteria
Inclusion criteria
- Fully understand and voluntarily sign an informed consent form, willing and able to follow the study process;
- Age range is 18-75 years old (inclusive);
- Pancreatic cancer confirmed by histology or cytology;
- Stage IV metastasis Pancreatic cancer patients;
- Have not received previous systematic first line anti-tumor treatment in the stage of metastatic pancreatic cancer;
- According to RECIST 1.1, there is at least one measurable lesion;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
- Expected survival time ≥ 12 weeks;
Exclusion criteria
- Use of systematic non-specific immunomodulatory therapy within 2weeks prior to the first dose；
- Presence of other malignancies in the past 5 years;
- Received major surgical surgery within 4 weeks before the first dose;
- Received palliative radiotherapy within 1 week before the first dose; received radical radiotherapy within 4 weeks before the first dose;
- Any known allergy to surufatinib or its components, camrelizumab, nab-paclitaxel, or gemcitabine;
- Received strong-inducers or strong-inhibitors of cytochrome P450 (CYP) 3A within 2 weeks or 5 half-lives (whichever is longer) before the first dose;
- Use of immunosuppressive drugs within 4 weeks before first dose;
- Known history of clinically significant liver disease, including active viral hepatitis infection or other active hepatitis or clinically significant moderate to severe cirrhosis;
- Patients who currently have hypertension that cannot be controlled by medication;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Nanjing Tianyinshan Hospital — Nanjing
- Tianjin Cancer Hospital — Tianjin
Identifiers
NCT: NCT06361888 · 2023-012-00CH1