What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as gemcitabine plus nab-paclitaxel (G/NP) and FOLFIRINOX, have notable side effects. G/NP often leads to neutropenia, fatigue, peripheral neuropathy, and gastrointestinal issues like nausea and diarrhea. FOLFIRINOX, which includes fluorouracil, leucovorin, irinotecan, and oxaliplatin, tends to cause more severe side effects, including neutropenia, thrombocytopenia, diarrhea, peripheral neuropathy, and fatigue. These side effects can significantly affect the patient's quality of life and require careful management.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including chemotherapy regimens such as gemcitabine plus nab-paclitaxel and FOLFIRINOX. These combinations are commonly used for their efficacy in treating advanced stages of the disease. While Pamrevlumab, which targets connective tissue growth factor (CTGF), is still under investigation, it represents a novel approach in the treatment landscape. Other FDA-approved treatments include targeted therapies like erlotinib, which is used in combination with gemcitabine, and immunotherapy agents such as pembrolizumab for patients with specific genetic markers.

What other types of research exist?

Promising novel alternatives to Pamrevlumab for pancreatic cancer patients include: 1) Immunotherapy agents such as checkpoint inhibitors (e.g., pembrolizumab, nivolumab) which target PD-1/PD-L1 pathways. 2) Combination therapies involving chemotherapy agents like gemcitabine plus nab-paclitaxel or FOLFIRINOX. 3) Targeted therapies such as PARP inhibitors (e.g., olaparib) for patients with BRCA mutations. 4) Novel agents in clinical trials, such as those targeting KRAS mutations or other specific molecular targets.

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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 up to approximately 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing pamrevlumab with standard chemotherapy in patients with advanced pancreatic cancer that can't be surgically removed. The goal is to see if the new drug can help shrink tumors enough to make surgery possible.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Secondary study objectives

Event-free Survival (EFS)

Number of Participants With Best Overall Objective Response as Assessed Using RECIST v1.1

Progression-free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Side effects data

From 2024 Phase 3 trial • 284 Patients • NCT03941093

59%

Fatigue

57%

Diarrhoea

48%

Nausea

38%

Anaemia

37%

Alopecia

36%

Neutrophil count decreased

35%

Decreased appetite

31%

Oedema peripheral

27%

Vomiting

27%

Constipation

25%

Platelet count decreased

24%

Abdominal pain

22%

Neutropenia

21%

Neuropathy peripheral

21%

Pyrexia

19%

Asthenia

18%

Stomatitis

17%

White blood cell count decreased

16%

Dysgeusia

16%

Peripheral sensory neuropathy

13%

Thrombocytopenia

13%

Rash

13%

Alanine aminotransferase increased

13%

Weight decreased

13%

Hypokalaemia

12%

Aspartate aminotransferase increased

12%

Dyspnoea

12%

Paraesthesia

11%

Insomnia

11%

Abdominal pain upper

11%

Hypotension

11%

Headache

10%

Pruritus

10%

Arthralgia

10%

Hypomagnesaemia

Abdominal distension

Back pain

Epistaxis

Rash maculo-papular

Dyspepsia

Cough

Dry mouth

Chills

Fall

Hyperglycaemia

Pulmonary embolism

Blood creatinine increased

Dehydration

Dizziness

Flatulence

Gastrooesophageal reflux disease

Blood alkaline phosphatase increased

Dry skin

Sepsis

Cholangitis

Haemorrhoids

Hypoalbuminaemia

Pneumonia

Anxiety

Muscular weakness

Pain in extremity

Hypertension

Lymphocyte count decreased

Influenza like illness

Acute kidney injury

Colitis

Febrile neutropenia

Depression

Biliary obstruction

Pneumonitis

Dysuria

Duodenal ulcer

Cancer pain

Cerebrovascular accident

Cholecystitis

Cardiac arrest

Hydrocele

Ascites

Duodenal obstruction

Dysphagia

Enterocolitis

Gastrointestinal disorder

Ileus

Inguinal hernia

Encephalopathy

Erythema

Intestinal ischaemia

Obstruction gastric

Varices oesophageal

Haemolytic uraemic syndrome

Death

Hypothermia

Jaundice cholestatic

Cholecystitis acute

Hyperbilirubinaemia

Malignant biliary obstruction

Pneumocystis jirovecii pneumonia

Bacteraemia

Biliary tract infection

Catheter site infection

Clostridium difficile infection

Acute respiratory distress syndrome

Enterocolitis infectious

Parainfluenzae virus infection

Post procedural infection

Septic shock

Tongue fungal infection

Hip fracture

Malnutrition

Urinary tract infection

Hyponatraemia

Respiratory failure

Acute myocardial infarction

Atrial fibrillation

Syncope

Transient ischaemic attack

Device occlusion

Aspiration

Gallbladder rupture

Cholecystitis infective

Escherichia sepsis

Lower respiratory tract infection

Neutropenic sepsis

Spinal osteoarthritis

Renal injury

Upper gastrointestinal haemorrhage

Femur fracture

Liver abscess

Jejunal perforation

Acute respiratory failure

Cholangitis infective

Joint dislocation

Pulmonary oedema

100%

80%

60%

40%

20%

Study treatment Arm

Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX

Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX

2019

Completed Phase 3

~290

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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.