A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer

NCT06361888 | Recruiting Phase 2 DMC

• 1 other identifier: 2023-012-00CH1
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the efficacy of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer

Conditions

Metastatic Pancreatic Cancer

Keywords

First-line treatment in patients

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Duration from the date of initial treatment to the date of death due to any cause

  From date of first dose of study drug until withdrawal of consent or death (up to approximately 20 months)

Secondary Outcomes (7)

• Progression-free Survival (PFS) (RECIST1.1)

  From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)

• Objective response rate (ORR)(RECIST1.1)

  From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)

• Duration of response (DoR)(RECIST1.1)

  From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)

• Disease control rate (DCR)(RECIST1.1)

  From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)

• Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)（only for phase III）

  From the within 7 days prior to the initiation of treatment to 30 days after the last administration

Study Arms (3)

Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine

EXPERIMENTAL

Drug: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine

Nab-paclitaxel Plus Gemcitabine

ACTIVE COMPARATOR

Drug: Nab-paclitaxel Plus Gemcitabine

Surufatinib with Nab-paclitaxel, and Gemcitabine

OTHER

Drug: Surufatinib with Nab-paclitaxel, and Gemcitabine

Interventions

Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine DRUG

Drug: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine 1. Surufatinib: 200mg, qd 2. Camrelizumab: 200mg, IV drip, Q3W, D1 3. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 4. Gemcitabine : 1000 mg/m2, IV drip, D1, D8

Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine

Nab-paclitaxel Plus Gemcitabine DRUG

Drug: Nab-paclitaxel Plus Gemcitabine 1. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 2. Gemcitabine : 1000 mg/m2, IV drip, D1, D8

Nab-paclitaxel Plus Gemcitabine

Surufatinib with Nab-paclitaxel, and Gemcitabine DRUG

Drug: Surufatinib with Nab-paclitaxel, and Gemcitabine 1. Surufatinib: 200mg, qd 2. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 3. Gemcitabine : 1000 mg/m2, IV drip, D1, D8

Surufatinib with Nab-paclitaxel, and 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:

• Fully understand and voluntarily sign an informed consent form, willing and able to follow the study process;
• Age range is 18-75 years old (inclusive);
• Pancreatic cancer confirmed by histology or cytology;
• Stage IV metastasis Pancreatic cancer patients;
• Have not received previous systematic first line anti-tumor treatment in the stage of metastatic pancreatic cancer;
• According to RECIST 1.1, there is at least one measurable lesion;
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
• Expected survival time ≥ 12 weeks;

You may not qualify if:

• Use of systematic anti-tumor therapy within 2weeks prior to the first dose；
• Presence of other malignancies in the past 5 years;
• Received major surgical surgery within 60 days before the first dose;
• Have received any surgery or invasive treatment within 4 weeks before the first use of the drug;
• Received palliative radiotherapy within 1 week before the first dose; received radical radiotherapy within 4 weeks before the first dose;
• Any known allergy to surufatinib or its components, camrelizumab, nab-paclitaxel, or gemcitabine;
• Received inducers or inhibitors of cytochrome P450 (CYP) 3A within 2 weeks or 5 half-lives (whichever is longer) before the first dose;
• Use of immunosuppressive drugs within 4 weeks before first dose;
• Known history of clinically significant liver disease, including active viral hepatitis infection or other active hepatitis or clinically significant moderate to severe cirrhosis;
• Patients who currently have hypertension that cannot be controlled by medication;

Sponsors & Collaborators

• Hutchmed: lead

Study Sites (2)

Nanjing Tianyinshan Hospital

Nanjing, Jiangsu, 210000, China

NOT YET RECRUITING

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

camrelizumab; 130-nm albumin-bound paclitaxel; Gemcitabine; surufatinib

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

Central Study Contacts

Panfeng Tan

CONTACT

+86 21 20671828; panfengt@hutch-med.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 12, 2024
• Study Start: May 8, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)