Surufatinib Combined With TAS-102 in Third-line and Later-line Therapy of Patients With Advanced Pancreatic Cancer

NCT05481463 | Completed Phase 2

• 1 other identifier: HMPL-012-SPRING-P104
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, single-arm, open-label, phase 2 clinical study, to explore the efficacy and safety of surufatinib combined with TAS-102 in third-line and later-line therapy of patients with advanced pancreatic cancer

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

  up to 24 months

Secondary Outcomes (5)

• disease control rate (DCR)

  up to 24 months

• overall survival (OS)

  up to 24 months

• objective response rate (ORR)

  up to 24 months

• quality of life (QoL)

  up to 24 months

• adverse events (AE)

  up to 24 months

Study Arms (1)

surufatinib combined with TAS-102

EXPERIMENTAL

Surufatinib 250mg,TAS-102 35mg/m2

Drug: Surufatinib; Drug: TAS-102

Interventions

Surufatinib DRUG

surufatinib,250mg, qd, po, 28 days for a cycle

surufatinib combined with TAS-102

TAS-102 DRUG

TAS-102,35mg/m2, po, d1-5, d8-12, bid, 28 days for a cycle

surufatinib combined with TAS-102

Eligibility Criteria

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

You may qualify if:

• Informed consent has been signed
• Histologically or cytologically confirmed unresectable, locally advanced or metastatic pancreatic cancer
• Age ≥ 18 years, ≤75 years, male or female
• ECOG PS：0-1, expected overall survival ≥12 months
• Patients who have previously received at least two systemic therapies for locally advanced or metastatic pancreatic cancer; patients with BRCA1/2 germline mutations have previously received platinum-containing regimens
• Patients must have at least one measurable liver metastases (RECIST 1.1)
• No serious organic diseases of the heart, lungs, brain and other organs
• Patients must have adequate organ and bone marrow function
• Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration

You may not qualify if:

• Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment
• Previously received VEGFR inhibitors or immune checkpoint inhibitors
• Patients had other malignant tumors in the past 5 years, except for the cured skin basal cell carcinoma and cervical carcinoma in situ
• Patients previously had brain metastasis or current brain metastasis
• Received any operation (except biopsy) or invasive treatment or operation (except venous catheterization, puncture and drainage, internal/external drainage surgery for obstructive jaundice, etc.) within 4 weeks before enrollment
• Clinically significant electrolyte abnormality
• Patient currently has uncontrolled hypertension, defined as: systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg
• Proteinuria ≥ 2+ (1.0g/24hr)
• Patients whose tumor is highly likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study as judged by the investigator
• Have evidence or history of bleeding tendency within 3 months, significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment
• Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; NYHA classification \> 2 Grade; ventricular arrhythmia requiring medical therapy; ECG showing QTc interval ≥ 480 ms
• Active or uncontrolled serious infection (≥CTCAE grade 2 infection)
• Unrelieved toxic reactions ≥ CTCAE grade 2 due to any previous anticancer treatment, excluding alopecia, lymphopenia and neurotoxicity of ≤ grade 2 caused by oxaliplatin
• Pregnant or lactating women
• Any other disease, with clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the judgment of investigator that the patient is not suitable for the the study drug (such as having epileptic seizures and require treatment), or would affect the interpretation of study results, or put patients at high risk

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer center of SunYat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Lu Y, Lin Q, Mo Y, Liu F, Zhang M, Huang R, Wang Y, Wang Y, Wang Z, Luo H, Guo G, Chen J, Liu Y, He M, Wang F, Wang F, Zhang D. Efficacy and safety of TAS-102 plus Surufatinib in third and later line metastatic pancreatic cancer: a prospective, single center and biomarker exploratory, phase II study. Mol Cancer. 2025 Oct 2;24(1):235. doi: 10.1186/s12943-025-02437-0.

  PMID: 41039600 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

surufatinib; trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Dongsheng Zhang, PhD

  Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: January 30, 2023
• Primary Completion: March 31, 2025
• Study Completion: May 10, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)