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

Metastatic Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06361888
• Other study ID #: 2023-012-00CH1
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 8, 2024
• Est. completion date: August 31, 2027

Study information

• Verified date: May 2024
• Source: Hutchmed
• Contact: Panfeng Tan
• Phone: +86 21 20671828
• Email: panfengt[@]hutch-med.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 482
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine
Drug: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine Surufatinib: 250mg or 200mg, qd Camrelizumab: 200mg, IV drip, Q3W, D1 Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 Gemcitabine : 1000 mg/m2, IV drip, D1, D8
• Nab-paclitaxel Plus Gemcitabine
Drug: Nab-paclitaxel Plus Gemcitabine Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 Gemcitabine : 1000 mg/m2, IV drip, D1, D8
• Surufatinib with Nab-paclitaxel, and Gemcitabine
Drug: Surufatinib with Nab-paclitaxel, and Gemcitabine Surufatinib: 250mg or 200mg, qd Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 Gemcitabine : 1000 mg/m2, IV drip, D1, D8

Locations

Country	Name	City	State
China	Nanjing Tianyinshan Hospital	Nanjing	Jiang Su
China	Tianjin Cancer Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Hutchmed

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-free Survival (PFS) (RECIST1.1)	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)
Secondary	Objective response rate (ORR)(RECIST1.1)	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)
Secondary	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.	From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)
Secondary	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.	From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)
Secondary	Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)	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
Secondary	Cancer Quality of Life Questionnaire - PAN26(EORTC QLQ-PAN26)	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