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

April 11, 2024 updated by: Hutchmed

A Multicenter, Randomized, Open-label, Active-controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine Versus Nab-paclitaxel Plus Gemcitabine as the First-line Treatment in Metastatic Pancreatic Cancer

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, randomized, open-label, active-controlled, phase II/III trial to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer

Study Type

Interventional

Enrollment (Estimated)

482

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiang Su
      • Nanjing, Jiang Su, China, 210000
        • Nanjing Tianyinshan Hospital
        • Contact:
          • Shukui Qin, Prof.
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Tianjin Cancer Hospital
        • Contact:
          • Jihui Hao, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Use of systematic anti-tumor therapy within 4 weeks prior to the first dose；
  2. Presence of other malignancies in the past 3 years;
  3. Received major surgical surgery within 60 days before the first dose;
  4. Have received any surgery or invasive treatment within 4 weeks before the first use of the drug;
  5. Received palliative radiotherapy within 1 week before the first dose; received radical radiotherapy within 4 weeks before the first dose;
  6. Any known allergy to surufatinib or its components, camrelizumab, nab-paclitaxel, or gemcitabine;
  7. Received inducers or inhibitors of cytochrome P450 (CYP) 3A and CYP2C8 within 2 weeks or 5 half-lives (whichever is longer) before the first dose;
  8. Use of immunosuppressive drugs within 4 weeks before first dose;
  9. Known history of clinically significant liver disease, including active viral hepatitis infection or other active hepatitis or clinically significant moderate to severe cirrhosis;
  10. Patients who currently have hypertension that cannot be controlled by medication;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine
Drug: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine

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

  1. Surufatinib: 250mg or 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
Active Comparator: Nab-paclitaxel Plus Gemcitabine
Drug: Nab-paclitaxel Plus Gemcitabine

Drug: Nab-paclitaxel Plus Gemcitabine

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

Drug: Surufatinib with Nab-paclitaxel, and Gemcitabine

  1. Surufatinib: 250mg or 200mg, qd
  2. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8
  3. Gemcitabine : 1000 mg/m2, IV drip, D1, D8

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From date of first dose of study drug until withdrawal of consent or death (up to approximately 20 months)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) (RECIST1.1)
Time Frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)
A duration from the date of initial treatment to disease progression or death of any cause.
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)
Time Frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)
The incidence of confirmed complete response or partial response
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)
Time Frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)
Duration from the first time reported partial response or complete response to the first time of disease progression or death.
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)
Time Frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)
Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.
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)
Time Frame: From the within 7 days prior to the initiation of treatment to 30 days after the last administration

The changes in health-related quality of life (HRQoL) score from baseline and the time to deterioration of symptoms (TTD) as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

- Core 30 (EORTC QLQ-C30)
From the within 7 days prior to the initiation of treatment to 30 days after the last administration
Cancer Quality of Life Questionnaire - PAN26(EORTC QLQ-PAN26)
Time Frame: From the within 7 days prior to the initiation of treatment to 30 days after the last administration

The changes in health-related quality of life (HRQoL) score from baseline and thehe time to deterioration of symptoms (TTD) as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

- PAN26 (EORTC QLQ-PAN26)
From the within 7 days prior to the initiation of treatment to 30 days after the last administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hutchmed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 31, 2024

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-012-00CH1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Pancreatic Cancer

Clinical Trials on Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe