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

Launched by RUI-HUA XU, MD, PHD · Mar 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for patients with advanced pancreatic cancer who have not responded to their first-line chemotherapy. The researchers want to see if a combination of three medications—surufatinib, camrelizumab, and mFOLFOX6—can help improve survival for these patients. The trial is currently not recruiting participants, but it aims to gather information on how effective this combination is and whether it can be safely used as a second-line therapy.

To be eligible for this trial, participants must be between 18 and 75 years old and have a confirmed diagnosis of metastatic pancreatic cancer that has not responded to previous treatment. They should have at least one measurable tumor to track the treatment's effectiveness and expect to live for at least 12 weeks. Participants will need to understand the study and sign a consent form before joining. It's important to note that certain individuals, such as those with specific health issues or who have received certain other treatments, may not be able to participate. If qualified, participants will receive the study treatment and will be closely monitored for any effects and overall health during the trial.

Gender

ALL

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.；