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

Advanced Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06329947
• Other study ID #: HMPL-012-SPRING-P106
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 22, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: May 2024
• Source: Sun Yat-sen University
• Contact: Rui Hua Xu, MD
• Phone: 13922206676
• Email: xurh[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 37
• Est. completion date: September 30, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.;

Related Conditions & MeSH terms

• Advanced Pancreatic Cancer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	SunYat-senUniversity Cancer Center	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Rui-hua Xu, MD, PhD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate (ORR)	Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.	Time Frame: up to 24 months
Secondary	disease control rate (DCR)	DCR was defined as the percentage of participants who have a confirmed complete response(CR) or partial response(PR) or stable disease(SD) per RECIST 1.1 as assessed by investigator	Time Frame: up to 24 months
Secondary	Progression-Free Survival (PFS)	PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator	Time Frame: up to 24 months
Secondary	overall survival (OS)	OS is the time from enrollment to death due to any cause.	Time Frame: up to 24 months
Secondary	quality of life (QoL)	Assessing the quality of life of cancer patients by QLQ-C30	Time Frame: up to 24 months
Secondary	adverse events (AE)	overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.	Time Frame: up to 24 months