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A Single-center, Prospective, Two Cohort Study of Surufatinib Combined With AG or AG in the First-line Treatment of Locally Advanced or Metastatic Pancreatic Cancer

ConditionPancreatic Cancer Metastatic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

This is a single-center, prospective, two cohort study to evaluate the efficacy and safety of surufatinib in combination with AG or AG alone in the first-line treatment of patients with locally advanced or metastatic pancreatic cancer.

Participants with previously received AG chemotherapy for 2 cycles with no disease progression will be enrolled:

Arm 1: Surufatinib plus AG chemotherapy (q3w) until disease progression/death/withdrawn; Arm 2: AG chemotherapy (q3w) until disease progression/death/withdrawn;

During the treatment period, imaging methods were used to evaluate the tumor status every 6 weeks (±7 days) until disease progression (RECIST 1.1) or death (during the patient's treatment) or toxicity was intolerable or other criteria for termination of study treatment specified in the protocol were met, and the tumor treatment and survival status after disease progression were recorded. Safety observation indicators include: AEs, changes in laboratory values, vital signs, and changes in electrocardiogram.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subjects voluntarily joined the study and signed the informed consent with good compliance and follow-up;

Unresectable, locally advanced or metastatic pancreatic cancer confirmed by histopathology or cytology;

Aged between 18 and 75 (including 18 and 75), male or female;

ECOG score: 0-1; Expected survival ≥12 weeks;

Disqualifiers

Participated in clinical trials of other antitumor drugs within 4 weeks before enrollment;

Prior treatment with VEGFR inhibitors or prior treatment with immune checkpoint inhibitors;

Patients with BRCA1/2 germ line mutation;

Patients with obstructive jaundice but failing to reach the expected yellow reduction;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Surufatinib, gemcitabine, nab-paclitaxel

    Drug

    Nab-paclitaxel: 125mg/m2 intravenously, d1, 8; every 3 weeks for a treatment cycle, did not exceed a maximum of 6 treatment cycles. Gemcitabine: 1000mg/m2, intravenous infusion greater than 30min, d1, 8, every 3 weeks for a treatment cycle. Surufatinib: 250mg, qd, po, every 3 weeks for a treatment cycle. Surufatinib and gemcitabine was continued until disease progression (PD, RECIST 1.1) or death (while the patient was on treatment) or toxicity became intolerant or other criteria for discontinuation of study therapy were met in the protocol. Allow adjustment of dosage according to protocol requirements, including suspension, lowering of dosage or permanent discontinuation.

  • Nab-paclitaxel, gemcitabine

    Drug

    Nab-paclitaxel: 125mg/m2 intravenously, d1, 8; every 3 weeks as a treatment cycle, should not exceed a maximum of 6 treatment cycles. Gemcitabine: 1000mg/m2, intravenous infusion greater than 30min, d1, 8, every 3 weeks as a treatment cycle, treatment until toxicity intolerance or disease progression, death, or other criteria for termination of study therapy as specified in the protocol. Allow adjustment of dosage according to protocol requirements, including suspension, lowering of dosage or permanent discontinuation.

Treatment groups

65 Participants
are divided into 2 treatment groups
Group A: Surufatinib in combination with gemcitabine and nab-paclitaxelExperimental treatment 1 intervention
Group B: Nab-paclitaxel combined with gemcitabineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival

Time frame
Defined as the time from the date of enrollment to the first documentation of disease progression or death from any cause, whichever occurs first.

Secondary outcomes

1

Objective Response Rate

Time frame
The proportion of patients whose tumors have decreased by a certain degree and remained so for a specified duration, including cases of complete response (CR) and partial response (PR). Tumor objective response is assessed using RECIST v1.1
2

Overall survival

Time frame
Overall survival (OS) refers to the duration from the date of enrollment to the date of death due to any cause.
3

Disease control rate

Time frame
Defined as the proportion of evaluable patients with complete response (CR), partial response (PR), or stable disease (SD) as confirmed cases. At baseline, subjects must have measurable tumor lesions; responses are evaluated according to RECIST v1.1

Other outcomes

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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