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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