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

NCT ID: NCT06329947

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-22
• Study Completion Date: 2026-09-30

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

Conditions

Advanced Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Surufatinib in combination with Camrelizumab and mFOLFOX6

Group Type: EXPERIMENTAL

Surufatinib 250mg/d qd once daily

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Camrelizumab 200mg,IV,Q2W once every 21 days during the maintenance treatment period, for a maximum of 2 years

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.；

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rui-hua Xu, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Rui-hua Xu, MD, PhD

Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rui Hua Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

SunYat-senUniversity Cancer Center

Guangzhou, , China

Countries

China

Central Contacts

Rui Hua Xu, MD

Role: CONTACT

xurh@sysucc.org.cn

13922206676

Hui Yan Luo, DR

Role: CONTACT

luohy@sysucc.org.cn

13719459226

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HMPL-012-SPRING-P106

Identifier Type: -

Identifier Source: org_study_id