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

NCT06329947 | Not Yet Recruiting Phase 2

• 1 other identifier: HMPL-012-SPRING-P106
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• disease control rate (DCR)

  Time Frame: up to 24 months

• Progression-Free Survival (PFS)

  Time Frame: up to 24 months

• overall survival (OS)

  Time Frame: up to 24 months

• quality of life (QoL)

  Time Frame: up to 24 months

• adverse events (AE)

  Time Frame: up to 24 months

Study Arms (1)

Experimental group

EXPERIMENTAL

Surufatinib in combination with Camrelizumab and mFOLFOX6

Drug: Surufatinib 250mg/d qd once daily

Interventions

Surufatinib 250mg/d qd once daily 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.

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have full understanding of this study and voluntarily sign the informed consent form;
• Male and Female aged between 18 and 75 years are eligible;
• Histologically or cytologically confirmed metastatic pancreatic cancer;
• 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;
• Presence of at least one measurable target lesion for further evaluation according to RECIST criteria;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
• Predicted survival ≥12 weeks;
• 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.

You may not qualify if:

• Participated in other anti-tumor drug clinical trials within 28 days;
• 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.);
• Have previously received anti-vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) targeted drug treatment;
• Those who are known to be allergic to any of the drugs in the study;
• Brain metastasis accompanied by symptoms or symptom control time \<2 months;
• 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);
• Insufficient bone marrow hematopoietic function (without blood transfusion within 14 days):
• Absolute neutrophil count (ANC) \<1.5×109/L;
• Platelets \<100×109/L;
• Hemoglobin \<8g/dL.
• Liver abnormalities:
• 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;
• Serum total bilirubin \>1.5×ULN (Gilber syndrome \>3×ULN);
• Decompensated cirrhosis (Child-Pugh liver function grade B or C);
• 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) ;

Sponsors & Collaborators

• Rui-hua Xu, MD, PhD: lead

Study Sites (1)

SunYat-senUniversity Cancer Center

Guangzhou, China

Location

MeSH Terms

Interventions

surufatinib; camrelizumab

Study Officials

• Rui Hua Xu, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Hua Xu, MD

CONTACT

13922206676; xurh@sysucc.org.cn

Hui Yan Luo, DR

CONTACT

13719459226; luohy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: March 26, 2024
• Study Start: May 22, 2024
• Primary Completion: January 1, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)