Clinical trial NCT06329947: A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD
Official title: A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Advanced Pancreatic Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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.；

Primary outcomes:
measure: objective response rate (ORR)
timeFrame: Time Frame: up to 24 months
Secondary outcomes:
measure: disease control rate (DCR)
timeFrame: Time Frame: up to 24 months
measure: Progression-Free Survival (PFS)
timeFrame: Time Frame: up to 24 months
measure: overall survival (OS)
timeFrame: Time Frame: up to 24 months
measure: quality of life (QoL)
timeFrame: Time Frame: up to 24 months
measure: adverse events (AE)
timeFrame: Time Frame: up to 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SunYat-senUniversity Cancer Center
Study officials:
affiliation: Sun Yat-sen University
name: Rui Hua Xu, MD
role: PRINCIPAL_INVESTIGATOR
References: