RecruitingPhase 2NCT05969171

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

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


Sponsor

Fudan University

Enrollment

65 participants

Start Date

Dec 5, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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no disease progression will be enrolled: Arm 1: Surufatinib plus AG chemotherapy (q3w) until disease progression/death/withdrawn; Arm 2: AG chemotherapy (q3w) until disease progression/death/withdrawn; During the treatment period, imaging methods were used to evaluate the tumor status every 6 weeks (±7 days) until disease progression (RECIST 1.1) or death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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a targeted drug called surufatinib to a standard chemotherapy regimen (gemcitabine plus nab-paclitaxel) improves outcomes for people with locally advanced or metastatic pancreatic cancer. Surufatinib blocks blood vessel growth in tumors and also has immune-boosting properties. This is a first-line maintenance approach for patients who have already started standard chemotherapy and their disease has not progressed. **You may be eligible if...** - You have confirmed locally advanced or metastatic pancreatic cancer (not surgically removable) - You are between 18 and 75 years old - You have already received 2 cycles of gemcitabine + nab-paclitaxel (AG regimen) with stable or responding disease - Your general health is good (ECOG 0–1) with a life expectancy of at least 12 weeks - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - Your cancer progressed during the initial 2 cycles of chemotherapy - You have serious heart, lung, or brain organ disease - You have received prior chemotherapy for metastatic pancreatic cancer (other than the 2 AG cycles described above) within 6 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSurufatinib, gemcitabine, nab-paclitaxel

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.

DRUGNab-paclitaxel, gemcitabine

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.


Locations(1)

Fudan University ShangHai Cancer Center

Shanghai, China

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NCT05969171


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