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Trial Title: A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD

NCT ID: NCT06329947

Condition: Advanced Pancreatic Cancer

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Surufatinib 250mg/d qd once daily
Description: mFOLFOX6( Oxaliplatin + Leucovorin + fluorouracil) Oxaliplatin 85mg/m2 d1+CF 400mg/m2 d1+5-FU 400mg/m2d1 /2400mg/m2 continuous intravenous injection (civ) for 46h, The drug is administered every 14 days for a total of 8-12 cycles.
Arm group label: Experimental group

Other name: Camrelizumab 200mg,IV,Q2W once every 21 days during the maintenance treatment period, for a maximum of 2 years

Summary: To preliminarily evaluate whether there is a survival benefit of surufatinib combined with camrelizumab and mFOLFOX6 as the second-line treatment for advanced pancreatic cancer, and to explore the feasibility of second-line and post-line treatment for advanced pancreatic cancer

Detailed description: Second-line clinical study of surufatinib in combination with Caralizumab advanced pancreatic cancer

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Have full understanding of this study and voluntarily sign the informed consent form; 2. Male and Female aged between 18 and 75 years are eligible; 3. Histologically or cytologically confirmed metastatic pancreatic cancer; 4. Patients who have previously failed first-line gemcitabine-based chemotherapy or have disease progression/recurrence during previous neoadjuvant/adjuvant treatment or within 6 months after the end of treatment are considered to have failed first-line systemic chemotherapy; neoadjuvant/adjuvant treatment plan Also gemcitabine-based chemotherapy; 5. Presence of at least one measurable target lesion for further evaluation according to RECIST criteria; 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 7. Predicted survival ≥12 weeks; 8. Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 6 months after the last dose of study drug. Exclusion Criteria: 1. Participated in other anti-tumor drug clinical trials within 28 days; 2. Have previously received any anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or acted on T cell costimulation or checkpoints Treatment with any other antibodies of the pathway (such as OX40, CD137, etc.); 3. Have previously received anti-vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) targeted drug treatment; 4. Those who are known to be allergic to any of the drugs in the study; 5. Brain metastasis accompanied by symptoms or symptom control time <2 months; 6. The subject has suffered from other malignant tumors in the past or at the same time within 5 years (except cured basal cell carcinoma of the skin and cervical cancer in situ); 7. Insufficient bone marrow hematopoietic function (without blood transfusion within 14 days): 1. Absolute neutrophil count (ANC) <1.5×109/L; 2. Platelets <100×109/L; 3. Hemoglobin <8g/dL. 8. Liver abnormalities: 1. When there is no liver metastasis, ALT, AST or ALP>2.5×the upper limit of the normal reference range (ULN); when there is liver metastasis, ALT, AST or ALP>5×ULN; 2. Serum total bilirubin >1.5×ULN (Gilber syndrome >3×ULN); 3. Decompensated cirrhosis (Child-Pugh liver function grade B or C); 4. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA copy number ≥2000IU/mL (those who are HBsAg positive and hepatitis B virus DNA copy number <2000IU/mL need to receive at least 2 weeks of anti-HBV treatment before taking the first dose) ; 5. Hepatitis C virus (HCV) antibody positive and HCVRNA test positive. 9. Kidney abnormalities: 1. Serum creatinine>1.5×ULN; 2. Routine urine test shows urine protein ≥++, and the 24-hour urine protein quantification is confirmed to be >1.0g; 3. Renal failure requiring hemodialysis or peritoneal dialysis; 4. Past history of nephrotic syndrome.;

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: SunYat-senUniversity Cancer Center

Address:
City: Guangzhou
Country: China

Start date: May 22, 2024

Completion date: September 30, 2026

Lead sponsor:
Agency: Rui-hua Xu, MD, PhD
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06329947

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