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Trial Title:
A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer
NCT ID:
NCT06361888
Condition:
Metastatic Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Gemcitabine
Conditions: Keywords:
First-line treatment in patients
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine
Description:
Drug: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine
1. Surufatinib: 250mg or 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
Arm group label:
Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine
Intervention type:
Drug
Intervention name:
Nab-paclitaxel Plus Gemcitabine
Description:
Drug: Nab-paclitaxel Plus Gemcitabine
1. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8
2. Gemcitabine : 1000 mg/m2, IV drip, D1, D8
Arm group label:
Nab-paclitaxel Plus Gemcitabine
Intervention type:
Drug
Intervention name:
Surufatinib with Nab-paclitaxel, and Gemcitabine
Description:
Drug: Surufatinib with Nab-paclitaxel, and Gemcitabine
1. Surufatinib: 250mg or 200mg, qd
2. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8
3. Gemcitabine : 1000 mg/m2, IV drip, D1, D8
Arm group label:
Surufatinib with Nab-paclitaxel, and Gemcitabine
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
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanjing Tianyinshan Hospital
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shukui Qin, Prof.
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Zip:
300000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jihui Hao, Prof.
Start date:
May 8, 2024
Completion date:
August 31, 2027
Lead sponsor:
Agency:
Hutchmed
Agency class:
Industry
Source:
Hutchmed
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06361888
