QL1706+Lenvatinib+AG Regimen as First-line Treatment for Advanced Metastatic Pancreatic Cancer
ConditionAdvance Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDu Juan
About this trial
The investigators plan to initiate a prospective, multicenter, phase II study, recruiting 80 patients with advanced pancreatic cancer who have not received prior treatment. This study aims to enhance the anti-tumor immune effect through the combination of QL1706+Lenvatinib+AG regimen, thereby improving the prognosis of patients with advanced metastatic pancreatic cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
a. Age ≥18 years, ECOG performance status ≤2, and expected survival of ≥3 months.
b. Patients with histologically or cytologically confirmed advanced metastatic pancreatic cancer.
c. At least one measurable lesion according to RECIST 1.1 criteria;
d. No prior anti-tumor treatment of any kind.
Disqualifiers
a. Prior receipt of systemic anti-tumor treatment, such as chemotherapy, radiotherapy, or other anti-tumor treatments.
b. Participation in another drug clinical trial within the past 4 weeks.
c. Subjects who, in the investigator's judgment, have the opportunity for surgery or are potentially operable (subjects who voluntarily forgo surgical treatment may be enrolled after investigator assessment and agreement).
d. Subjects with moderate ascites requiring drainage (except for those with minimal ascites shown on imaging without symptoms).
Trial design
Design model
Single group
Treatments tested in this trial
QL1706+Lenvatinib+AG Regimen
DrugParticipants will receive QL1706 combination with Lenvatinib and AG regimen for 8 cycles. Subsequently, the enrolled patients will continue to receive maintenance therapy with QL1706 and Lenvatinib until disease progression (PD) is observed, intolerable adverse events occur, or the investigator deems it inappropriate for the subject to continue treatment.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: QL1706+Lenvatinib+AG RegimenExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Median Progression-Free Survival (mPFS)
Time frame
up to 24 monthsSecondary outcomes
1
Objective Response Rate (ORR)
Time frame
up to 24 months2
Disease Control Rate (DCR)
Time frame
up to 24 months3
Median Overall Survival (mOS)
Time frame
up to 24 months4
Adverse Events（AEs）
Time frame
up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Du Juan
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor institution
Source ClinicalTrials.gov