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Metastatic Pancreatic CancerPhase 2/3NCT06361888

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

A Phase 2/3 study testing Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine, Nab-paclitaxel Plus Gemcitabine and Surufatinib with Nab-paclitaxel, and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Hutchmed at 52 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine, Nab-paclitaxel Plus Gemcitabine and Surufatinib with Nab-paclitaxel, and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
502 participants
Where
52 sitesChina
Study dates
8 May 2024to 31 May 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • Use of systematic non-specific immunomodulatory therapy within 2weeks prior to the first dose；
  • Presence of other malignancies in the past 5 years;
  • Received major surgical surgery within 4 weeks before the first dose;
  • 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 strong-inducers or strong-inhibitors of cytochrome P450 (CYP) 3A within 2 weeks or 5 half-lives (whichever is longer) before the first dose;
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  • 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;

Trial locations and contacts

52 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Panfeng Tan contact

+86 21 20671828

panfengt@hutch-med.com

52 sites in 1 country

China52 sites, 52 recruiting

  • Anyang Cancer Hospital

    Anyang, Henan

    Jin Xia

    Jin Xia

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

    Chunyi Hao

    Chunyi Hao

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

    Xiang Wang

    Xiang Wang

    Recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality

    Chunhui Yuan

    Chunhui Yuan

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin

    Xueying Zhang

    Xueying Zhang

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Zhenyang Liu

    Zhenyang Liu

    Recruiting

  • XiangYa Hospital CentralSouth University

    Changsha, Hunan

    Xuejun Gong

    Xuejun Gong

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan

    Haiqing Wang

    Haiqing Wang

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Dan Cao

    Dan Cao

    Recruiting

  • Chongqing General Hospital

    Chongqing, Chongqing Municipality

    Zhibin Luo

    Zhibin Luo

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality

    Yi Gong

    Yi Gong

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    Sha Huang

    Sha Huang

    Recruiting

  • Guangdong Provincial People's Hospital

    Guandong, Guangzhou

    Rufu Chen

    Rufu Chen

    Recruiting

  • Hainan General Hospital

    Haikou, Hainan

    Jinfang Zheng

    Jinfang Zheng

    Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Jiaqi Chen

    Jiaqi Chen

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Qi Xu

    Qi Xu

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

    Yiping Mou

    Yiping Mou

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    Yanqiao Zhang

    Yanqiao Zhang

    Recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui

    Yueyin Pan

    Yueyin Pan

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong

    He Tian

    He Tian

    Recruiting

  • Affiliated Hospital Of Jining Medical University

    Jining, Shandong

    Junye Wang

    Recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan

    Lin Xie

    Lin Xie

    Recruiting

  • Linyi People's Hospital

    Linyi, Shandong

    Zhongmin Zhang

    Zhongmin Zhang

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi

    Huiqing Zhang

    Huiqin Zhang

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Yong Li

    Yong Li

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

    Huayun Zhu

    Huayun Zhu

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

    Juan Du

    Juan Du

    Recruiting

  • Nanjing Tianyinshan Hospital

    Nanjing, Jiangsu

    Shukui Qin

    Chen Xun

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Jie Ma

    Jie Ma

    Recruiting

  • Nantong Cancer Hospital

    Nantong, Jiangsu

    Aibing Xu

    Aibing Xu

    Recruiting

  • First Hospital of Qinhuangdao

    Qinhuangdao, Hebei

    Liming Gao

    Liming Gao

    Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality

    Deliang Fu

    Deliang Fu

    Recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

    Boyong Shen

    Boyong Shen

    Recruiting

  • ZhongShan Hospital Fudan University

    Shanghai, Shanghai Municipality

    Liang Liu

    Liang Liu

    Recruiting

  • Liaoning Cancer Hospital

    Shenyang, Liaoning

    Xiangdong Hua

    Xiangdong Hua

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning

    Xiujuan Qu

    Xiujuan Qu

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

    Shenzhen, Guangdong

    Ying Wang

    Ying Wang

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

    Wei Li

    Wei Li

    Recruiting

  • Shanxi Provincial Cancer Hospitial

    Taiyuan, Shanxi

    Wenhui Yang

    Wenhui Yang

    Recruiting

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin, Tianjin Municipality

    Huikai Li

    Huikai Li

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality

    Jihui Hao

    Jihui Hao

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Hongwei Sun

    Hongwei Sun

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei

    Dongde Wu

    Dongde Wu

    Recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Xianglin Yuan

    Xianglin Yuan

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Heshui Wu

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Tao Zhang

    Tao Zhang

    Recruiting

  • Jiangyin People's Hospital

    Wuxi, Jiangsu

    Lichun Deng

    Lichun Deng

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

    Enxiao Li

    Enxiao Li

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

    Jianbo Chen

    Jianbo Chen

    Recruiting

  • The First Affiliated Hospital of Henan Medical University

    Xinxiang, Henan

    Yinghua Ji

    Yinghua Ji

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Xiaobing Chen

    Xiaobing Chen

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Yanru Qin

    Yanru Qin

    Recruiting

Other trials in China

About this study

Official title: 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

Read the 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

Being tested
Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine, Nab-paclitaxel Plus Gemcitabine, Surufatinib with Nab-paclitaxel, and Gemcitabine
Keywords
First-line treatment in patients
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and GemcitabineDrug

    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

  • Nab-paclitaxel Plus GemcitabineDrug

    Drug: Nab-paclitaxel Plus Gemcitabine

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

  • Surufatinib with Nab-paclitaxel, and GemcitabineDrug

    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
Study groups in NCT06361888
Study groupRoleWhat they receive
Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and GemcitabineExperimentalNot described
Receives: Drug: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine
Nab-paclitaxel Plus GemcitabineActive comparatorNot described
Receives: Drug: Nab-paclitaxel Plus Gemcitabine
Surufatinib with Nab-paclitaxel, and GemcitabineOtherNot described
Receives: Drug: Surufatinib with Nab-paclitaxel, and Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

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

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

Secondary outcomes (6)

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

    A duration from the date of initial treatment to disease progression or death of any cause.

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

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

    The incidence of confirmed complete response or partial response

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

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

    Duration from the first time reported partial response or complete response to the first time of disease progression or death.

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

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

    Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.

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

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

    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)

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

  6. Cancer Quality of Life Questionnaire - PAN26(EORTC QLQ-PAN26)（only for phase III）

    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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2024
  2. Study start8 May 2024
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
502 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06361888
Sponsor's protocol ID
2023-012-00CH1
Status last verified
Sep 2026
First submitted
26 Mar 2024
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine, Nab-paclitaxel Plus Gemcitabine and Surufatinib with Nab-paclitaxel, and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Hutchmed at 52 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Panfeng Tan (+86 21 20671828, panfengt@hutch-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From date of first dose of study drug until withdrawal of consent or death (up to approximately 20 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06361888.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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