Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic Pancreatic Cancer

NCT05218889 | Recruiting Phase 1

• 1 other identifier: HMPL-012-SPRING-P101
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to explore the efficacy and safety of surufatinib combined with camrelizumab and AS (nab-paclitaxel and S-1) as first-line treatment compared with AG (nab-paclitaxel and gemcitabine) in unresectable advanced or metastatic pancreatic cancer.

Conditions

Pancreatic Cancer; PDAC - Pancreatic Ductal Adenocarcinoma; Pancreas Cancer; Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (3)

• DLTs

  Dose-limiting toxicities will be evaluated by the investigators at the first cycle in Ib phase

  Up to 21 days after the first dose of surufatinib

• RP2D

  The RP2D is defined as the dose level of surufatinib chosen by the investigators for the phase II experimental arm, based on DLTs

  Up to 21 days after the first dose of surufatinib

• ORR

  The proportion of patients with a confirmed complete response or partial response

  up to 3 years

Secondary Outcomes (6)

• PFS

  up to 3 years

• DCR

  up to 3 years

• OS

  up to 3 years

• DOR

  up to 3 years

• TTR

  up to 3 years

Study Arms (2)

surufatinib + camrelizumab + nab-paclitaxel + S-1

EXPERIMENTAL

Drug: surufatinib + camrelizumab + nab-paclitaxel + S-1

nab-paclitaxel + gemcitabine

ACTIVE COMPARATOR

Drug: nab-paclitaxel + gemcitabine

Interventions

surufatinib + camrelizumab + nab-paclitaxel + S-1 DRUG

phase 1b: surufatinib 200 or 250 mg/d, qd po; camrelizumab: 200mg, I.V., D1, Q3W; nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; S-1: 40mg bid, D1-14, Q3W; DLTs will be evaluated at first cycle; phase 2: surufatinib RP2D + camrelizumab + nab-paclitaxel + S-1 when evaluated SD, PR or CR after 4-6 cycles (according to RECIST 1.1), followed by maintenance treatment: surufatinib + camrelizumab + S-1

surufatinib + camrelizumab + nab-paclitaxel + S-1

nab-paclitaxel + gemcitabine DRUG

nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W

nab-paclitaxel + gemcitabine

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 fully understood this study and voluntarily signed the informed consent form;
• Patients with histologically or cytologically confirmed unresectable, locally advanced, or metastatic pancreatic ductal adenocarcinoma;
• Age 18-75 years old (inclusive);
• No prior systemic therapy for advanced pancreatic carcinoma;
• ECOG PS 0-1;
• Must have at least one measurable lesion, with the longest diameter of at least 10 mm as measured by spiral CT scan, or at least 20 mm as measured by conventional CT scan (according to Response Evaluation Criteria in Solid Tumors, i.e. RECIST v1.1);
• Expected survival ≥ 3 months;
• The functions of vital organs meet the following requirements (the use of any blood components and cell growth factors within \*14 days before enrollment is not allowed):
• Absolute neutrophil count ≥1.5×109/L; Platelets ≥100×109/L; Haemoglobin ≥90 g/L; Total bilirubin \< 1.5 × ULN; ALT and/or AST \< 1.5 × ULN ( \< 3 × ULN for patients with metastases to liver); Serum creatinine \< 1.5 × ULN; Endogenous creatinine clearance ≥50 mL/min;
• Women of childbearing potential must use effective contraceptive measures;
• Good compliance and cooperative with follow-up.

You may not qualify if:

• Unable to comply with the study protocol or study procedures;
• Previously received treatment with VEGFR inhibitors, or previously used ICI treatment;
• Participating in or having participated in other drug clinical trials within 4 weeks prior to enrollment;
• Have received transfusion therapy, blood products, and hematopoietic factors, such as albumin and G-CSF, within 14 days prior to enrollment;
• Brachytherapy (radioactive seed implantation) within 60 days prior to enrollment;
• Have received other systemic anti-tumor treatments within 4 weeks prior to enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy, and immunotherapy;
• Have received any surgery or invasive treatment or procedure within 4 weeks prior to enrollment (excluding intravenous catheterization, paracentesis drainage, etc.);
• Undergone major surgery within 60 days prior to enrollment or the surgical incision has not completely healed;
• Have received local anti-tumor treatments within 4 weeks prior to enrollment, such as hepatic arterial interventional embolism, cryoablation or radiofrequency ablation of metastases to liver;
• The patient currently has hypertension uncontrolled by medication, defined as: blood pressure systolic ≥140 mmHg and/or blood pressure diastolic ≥90 mmHg;
• Protein urine ≥2+, or 24-hour protein urine amount ≥1.0 g on urinalysis;
• Uncontrollable malignant ascites (defined as ascites that cannot be controlled by diuretics or paracentesis as judged by the investigator);
• Clinically significant electrolyte abnormalities as judged by the investigator;
• Liver metastases accounted for half or more of the total liver volume as determined by the investigator;
• Clinically significant cardiovascular disorders, including but not limited to acute myocardial infarction within 6 months prior to enrollment, severe/unstable angina pectoris, or coronary artery bypass surgery; cardiac failure congestive with NYHA classification \> Class II; ventricular arrhythmia requiring drug therapy; LVEF (left ventricular ejection fraction) \<50%;

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

surufatinib; camrelizumab; 130-nm albumin-bound paclitaxel; S 1 (combination); Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 1, 2022
• Study Start: August 4, 2021
• Primary Completion: December 16, 2024
• Study Completion: June 1, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)