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

September 14, 2026 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 surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer

Study Overview

Status

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)

502

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
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Provincial Hospital
        • Principal Investigator:
          • Yueyin Pan
        • Contact:
          • Yueyin Pan
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Xiang Wang
        • Principal Investigator:
          • Xiang Wang
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Chunhui Yuan
        • Principal Investigator:
          • Chunhui Yuan
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Chunyi Hao
        • Principal Investigator:
          • Chunyi Hao
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:
          • Yi Gong
        • Principal Investigator:
          • Yi Gong
        • Principal Investigator:
          • Dewei Li
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Chongqing General Hospital
        • Contact:
          • Zhibin Luo
        • Principal Investigator:
          • Zhibin Luo
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Sha Huang
        • Principal Investigator:
          • Sha Huang
      • Xiamen, Fujian, China
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Jianbo Chen
        • Principal Investigator:
          • Jianbo Chen
    • Guangdong
      • Shenzhen, Guangdong, China
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
        • Contact:
          • Ying Wang
        • Principal Investigator:
          • Ying Wang
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Jie Ma
        • Principal Investigator:
          • Jie Ma
    • Guangzhou
      • Guandong, Guangzhou, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Rufu Chen
        • Principal Investigator:
          • Rufu Chen
    • Hainan
      • Haikou, Hainan, China
        • Recruiting
        • Hainan General Hospital
        • Contact:
          • Jinfang Zheng
        • Principal Investigator:
          • Jinfang Zheng
    • Hebei
      • Qinhuangdao, Hebei, China
        • Recruiting
        • First Hospital of Qinhuangdao
        • Contact:
          • Liming Gao
        • Principal Investigator:
          • Liming Gao
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Yanqiao Zhang
        • Principal Investigator:
          • Yanqiao Zhang
    • Henan
      • Anyang, Henan, China
        • Recruiting
        • Anyang Cancer Hospital
        • Principal Investigator:
          • Jin Xia
        • Contact:
          • Jin Xia
      • Xinxiang, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Henan Medical University
        • Contact:
          • Yinghua Ji
        • Principal Investigator:
          • Yinghua Ji
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Xiaobing Chen
        • Principal Investigator:
          • Xiaobing Chen
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Principal Investigator:
          • Yanru Qin
        • Contact:
          • Yanru Qin
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Principal Investigator:
          • Tao Zhang
        • Contact:
          • Tao Zhang
      • Wuhan, Hubei, China
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:
          • Dongde Wu
        • Principal Investigator:
          • Dongde Wu
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Principal Investigator:
          • Xianglin Yuan
        • Contact:
          • Xianglin Yuan
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Zhenyang Liu
        • Principal Investigator:
          • Zhenyang Liu
      • Changsha, Hunan, China
        • Recruiting
        • XiangYa Hospital CentralSouth University
        • Contact:
          • Xuejun Gong
        • Principal Investigator:
          • Xuejun Gong
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Cancer Hospital
        • Contact:
          • Huayun Zhu
        • Principal Investigator:
          • Huayun Zhu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
          • Juan Du
        • Principal Investigator:
          • Juan Du
      • Nanjing, Jiangsu, China
        • Recruiting
        • Nanjing Tianyinshan Hospital
        • Contact:
          • Shukui Qin
        • Principal Investigator:
          • Chen Xun
      • Nantong, Jiangsu, China
        • Recruiting
        • Nantong Cancer Hospital
        • Contact:
          • Aibing Xu
        • Principal Investigator:
          • Aibing Xu
      • Suzhou, Jiangsu, China
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Principal Investigator:
          • Wei Li
        • Contact:
          • Wei Li
      • Wuxi, Jiangsu, China
        • Recruiting
        • Jiangyin People's Hospital
        • Contact:
          • Lichun Deng
        • Principal Investigator:
          • Lichun Deng
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Yong Li
        • Contact:
          • Yong Li
      • Nanchang, Jiangxi, China
        • Recruiting
        • Jiangxi Cancer Hospital
        • Contact:
          • Huiqing Zhang
        • Principal Investigator:
          • Huiqin Zhang
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • Jilin cancer hospital
        • Contact:
          • Xueying Zhang
        • Principal Investigator:
          • Xueying Zhang
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
          • Xiujuan Qu
        • Principal Investigator:
          • Xiujuan Qu
      • Shenyang, Liaoning, China
        • Recruiting
        • Liaoning Cancer Hospital
        • Contact:
          • Xiangdong Hua
        • Principal Investigator:
          • Xiangdong Hua
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:
          • He Tian
        • Principal Investigator:
          • Yuping Sun
        • Principal Investigator:
          • He Tian
      • Jining, Shandong, China
        • Recruiting
        • Affiliated Hospital of Jining Medical University
        • Contact:
          • Junye Wang
      • Linyi, Shandong, China
        • Recruiting
        • Linyi People's Hospital
        • Contact:
          • Zhongmin Zhang
        • Principal Investigator:
          • Zhongmin Zhang
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Huashan Hospital, Fudan University
        • Contact:
          • Deliang Fu
        • Principal Investigator:
          • Deliang Fu
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
          • Boyong Shen
        • Principal Investigator:
          • Boyong Shen
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Zhongshan Hospital Fudan University
        • Contact:
          • Liang Liu
        • Principal Investigator:
          • Liang Liu
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Provincial Cancer Hospitial
        • Principal Investigator:
          • Wenhui Yang
        • Contact:
          • Wenhui Yang
      • Xi’an, Shanxi, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Enxiao Li
        • Principal Investigator:
          • Enxiao Li
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Sichuan Cancer Hospital
        • Contact:
          • Haiqing Wang
        • Principal Investigator:
          • Haiqing Wang
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Dan Cao
        • Principal Investigator:
          • Dan Cao
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Recruiting
        • Tianjin Cancer Hospital
        • Principal Investigator:
          • Jihui Hao
        • Contact:
          • Jihui Hao
      • Tianjin, Tianjin Municipality, China
        • Recruiting
        • Tianjin Cancer Hospital Airport Hospital
        • Contact:
          • Huikai Li
        • Principal Investigator:
          • Huikai Li
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • Yunnan Cancer Hospital
        • Principal Investigator:
          • Lin Xie
        • Contact:
          • Lin Xie
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Qi Xu
        • Principal Investigator:
          • Qi Xu
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
          • Jiaqi Chen
        • Principal Investigator:
          • Jiaqi Chen
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
          • Yiping Mou
        • Principal Investigator:
          • Yiping Mou
      • Wenzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Hongwei Sun
        • Principal Investigator:
          • Hongwei Sun

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 first line 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 non-specific immunomodulatory therapy within 2weeks prior to the first dose；
  2. Presence of other malignancies in the past 5 years;
  3. Received major surgical surgery within 4 weeks before the first dose;
  4. Received palliative radiotherapy within 1 week before the first dose; received radical radiotherapy within 4 weeks before the first dose;
  5. Any known allergy to surufatinib or its components, camrelizumab, nab-paclitaxel, or gemcitabine;
  6. Received strong-inducers or strong-inhibitors of cytochrome P450 (CYP) 3A within 2 weeks or 5 half-lives (whichever is longer) before the first dose;
  7. Use of immunosuppressive drugs within 4 weeks before first dose;
  8. Known history of clinically significant liver disease, including active viral hepatitis infection or other active hepatitis or clinically significant moderate to severe cirrhosis;
  9. 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: 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: 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)（only for phase III）
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)（only for phase III）
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

Investigators

  • Principal Investigator: Shukui Qin, Nanjing Tianyinshan Hospital
  • Principal Investigator: Jihui Hao, Tianjin Cancer Hospital

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 (Actual)

May 8, 2024

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

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)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

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.

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