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

Phase 2

Recruiting

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Drug: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine; Drug: Nab-paclitaxel Plus Gemcitabine; Drug: Surufatinib with Nab-paclitaxel, and Gemcitabine

• Registration Number: NCT06361888
• Lead Sponsor: Hutchmed

Brief 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

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 Timeline

• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-12
• Status Verified: 2024-05
• Study Start: 2024-05-08
• Last Update Submitted: 2024-05-12
• Last Update Posted: 2024-05-14
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 482

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine	Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine	-
Nab-paclitaxel Plus Gemcitabine	Nab-paclitaxel Plus Gemcitabine	-
Surufatinib with Nab-paclitaxel, and Gemcitabine	Surufatinib with Nab-paclitaxel, and Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	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

Secondary Outcome Measures

Name	Time	Method
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)	A duration from the date of initial treatment to disease progression or death of any cause.
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)	The incidence of confirmed complete response or partial response
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)	Duration from the first time reported partial response or complete response to the first time of disease progression or death.
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)	Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.
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	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)
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	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)

Trial Locations

Locations (2)

Nanjing Tianyinshan Hospital; 🇨🇳 Nanjing, Jiang Su, China

Tianjin Cancer Hospital; 🇨🇳 Tianjin, Tianjin, China