🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06329947
Starting soon Phase 2

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

NCT06329947 · tracked via the Priya Life Science China tracker
Sponsor
Rui-hua Xu, MD, PhD
Phase
Phase 2
Started
2024-05-22
Last updated
2024-05-08

Condition(s) studied

Advanced Pancreatic Cancer

Investigational drug(s) / intervention(s)

Surufatinib 250mg/d qd once daily

Surufatinib 250mg/d qd once daily: 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.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
SunYat-senUniversity Cancer Center Guangzhou China

More Rui-hua Xu, MD, PhD trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06329947 on ClinicalTrials.gov ↗ ← All trials in China