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

Rui-hua Xu, MD, PhD

Status and phase: Not yet enrolling; Phase 2

Conditions: Advanced Pancreatic Cancer

Treatments: Drug: Surufatinib 250mg/d qd once daily

Study type: Interventional

Funder types: Other

Identifiers

NCT06329947

HMPL-012-SPRING-P106

Details and patient eligibility

About

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

Full description

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

Enrollment: 37 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.；

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Experimental group

Experimental group

Description:

Surufatinib in combination with Camrelizumab and mFOLFOX6

Treatment:

Drug: Surufatinib 250mg/d qd once daily