Surufatinib Combined With Sintilimab and AG in First-line Therapy of Patients With Locally Advanced or Metastatic Pancreatic Cancer

NCT05481476 | Active Not Recruiting Phase 2

• 1 other identifier: HMPL-012-SPRING-P103
• Study Type: interventional
• Target: 32
• 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 sintilimab and AG in first-line therapy of patients with locally advanced or metastatic pancreatic cancer.

Conditions

Pancreatic Neoplasms

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.

  up to 24 months

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  up to 24 months

• disease control rate (DCR)

  up to 24 months

• overall survival (OS)

  up to 24 months

• Molecular markers and imaging parameters predicting therapeutic efficacy

  up to 24 months

• adverse events (AE)

  up to 24 months

Study Arms (1)

surufatinib combined with sintilimab and AG

EXPERIMENTAL

Drug: Surufatinib; Drug: Sintilimab; Drug: AG

Interventions

Surufatinib DRUG

250mg, qd, po, 21 days for a cycle

surufatinib combined with sintilimab and AG

Sintilimab DRUG

200mg, ivgtt, d1, 21 days for a cycle, up to 2 years

surufatinib combined with sintilimab and AG

AG DRUG

nab-paclitaxel (125mg/ m2, ivgtt, d1, 8), Gemcitabine (1000mg/ m2, intravenous infusion over 30min, d1, 8), 21 days for a cycle, up to 6 cycles

surufatinib combined with sintilimab and AG

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 not previously received systemic therapy for locally advanced or metastatic pancreatic cancer
• Patients with distant metastases after surgery, who have received one regimen of adjuvant chemotherapy and have recurred \> 6 months from adjuvant therapy can be enrolled
• 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 with BRCA1/2 germline mutations
• Patients with obstructive jaundice but less than expected jaundice
• 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
• Investigator determines that the liver metastases account for 70% or more of the total liver volume
• 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
• Received local anti-tumor therapy such as hepatic artery interventional embolization, cryoablation or radiofrequency ablation of liver metastases 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 period 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer center of SunYat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

surufatinib; sintilimab

Condition Hierarchy (Ancestors)

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

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: December 12, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

CN (1)