GnP Combined With SHR-1701 and Apatinib as First-Line Treatment for Locally Advanced or Metastatic PDAC
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital
About this trial
The goal of this clinical trial is to evaluate the safety and efficacy of GnP combined with SHR-1701 and Apatinib as first-line treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
SHR-1701
DrugSHR-1701 is administered by intravenous infusion at a dose of 30 mg/kg once every 3 weeks (Q3W). The dose may be adjusted to the recommended phase II dose (RP2D) determined during the phase Ib safety run-in phase.
Apatinib
DrugApatinib is administered orally at a dose of 250 mg once daily (QD). The dose may be adjusted to the recommended phase II dose (RP2D) determined during the phase Ib safety run-in phase.
gemcitabine
DrugGemcitabine is administered by intravenous infusion at a dose of 1000 mg/m² on days 1 and 8 of each 3-week cycle.
Nab-paclitaxel
DrugNab-paclitaxel is administered by intravenous infusion at a dose of 125 mg/m² on days 1 and 8 of each 3-week cycle.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: SHR-1701 combined with Apatinib and GnPExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Recommended Phase II Dose (RP2D)
RP2D will be determined on the basis of evaluation on safety and efficacy data in Phase Ib.
Time frame
through phase I study completion, an average of 5 months2
Objective Response Rate (ORR)
Proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.
Time frame
through study completion, an average of 2 yearsSecondary outcomes
1
Overall Survival (OS)
Time from the first administration of study treatment to death from any cause. Participants who are alive or lost to follow-up at the time of analysis will be censored at the date of their last known survival assessment.
Time frame
through study completion, an average of 2 years2
Progression-Free Survival (PFS)
Time from the first administration of study treatment to the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first. Participants who are alive and have not experienced disease progression will be censored at the date of the last tumor assessment.
Time frame
through study completion, an average of 2 years3
Disease Control Rate (DCR)
Proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) as the best overall response according to RECIST v1.1 criteria.
Time frame
through study completion, an average of 2 years4
Duration of Response (DOR)
Time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.
Time frame
through study completion, an average of 2 yearsSponsors and contacts
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Source ClinicalTrials.gov
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