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

ConditionMetastatic Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHutchmed

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Drug

    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 Gemcitabine

    Drug

    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 Gemcitabine

    Drug

    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

Treatment groups

502 Participants
are divided into 3 treatment groups
Group A: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and GemcitabineExperimental treatment 1 intervention
Group B: Nab-paclitaxel Plus GemcitabineActive comparator 1 intervention
Group C: Surufatinib with Nab-paclitaxel, and GemcitabineOther 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

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

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

Secondary outcomes

1

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

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

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)
2

Objective response rate (ORR)(RECIST1.1)

The incidence of confirmed complete response or partial response

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)
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.

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)
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.

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hutchmed

Lead sponsor

Source ClinicalTrials.gov
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