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Chemotherapy

Pamrevlumab + Chemotherapy for Pancreatic Cancer (LAPIS Trial)

Phase 3
Waitlist Available
Research Sponsored by FibroGen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization until disease progression or death, whichever occurs first (assessed up to 6 years)
Awards & highlights

Summary

This trial is testing a new cancer treatment on people with pancreatic cancer that has spread and cannot be removed by surgery.

Who is the study for?
Adults over 18 with locally advanced, unresectable pancreatic cancer can join this trial. They must have good organ function, no recent other cancers (except certain skin cancers), and not be on drugs affecting liver enzymes. Participants need to use effective contraception and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a new drug called Pamrevlumab combined with chemotherapy (Gemcitabine plus Nab-paclitaxel or FOLFIRINOX) compared to placebo with the same chemotherapies in treating pancreatic cancer before surgery.See study design
What are the potential side effects?
Possible side effects include reactions related to monoclonal antibodies like Pamrevlumab, as well as those associated with chemotherapy such as fatigue, nausea, low blood counts, peripheral neuropathy (nerve pain), and increased risk of infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization until disease progression or death, whichever occurs first (assessed up to 6 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization until disease progression or death, whichever occurs first (assessed up to 6 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Best Overall Objective Response Rate (ORR), as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Event-free survival (EFS)
Progression-free survival (PFS)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm AExperimental Treatment1 Intervention
Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX
Group II: Arm BPlacebo Group1 Intervention
Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pancreatic cancer include chemotherapy regimens like gemcitabine plus nab-paclitaxel and FOLFIRINOX. Gemcitabine inhibits DNA synthesis, while nab-paclitaxel disrupts microtubule function, both leading to cancer cell death. FOLFIRINOX combines leucovorin, fluorouracil, irinotecan, and oxaliplatin, which work synergistically to inhibit DNA replication and repair, causing cell death. Pamrevlumab, an investigational drug, inhibits connective tissue growth factor (CTGF), which is involved in tumor growth and metastasis. These treatments are crucial as they target the aggressive nature of pancreatic cancer, aiming to slow disease progression and improve patient outcomes.
Promising new therapies in advanced pancreatic adenocarcinomas.

Find a Location

Who is running the clinical trial?

FibroGenLead Sponsor
57 Previous Clinical Trials
15,023 Total Patients Enrolled

Media Library

FOLFIRINOX (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03941093 — Phase 3
Pancreatic Cancer Research Study Groups: Arm A, Arm B
Pancreatic Cancer Clinical Trial 2023: FOLFIRINOX Highlights & Side Effects. Trial Name: NCT03941093 — Phase 3
FOLFIRINOX (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03941093 — Phase 3
Pancreatic Cancer Patient Testimony for trial: Trial Name: NCT03941093 — Phase 3
~46 spots leftby Jul 2025