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CEND-1 + FOLFIRINOX for Digestive Cancer (CENDIFOX Trial)

Phase 1 & 2

Recruiting

Led By Anup Kasi, MD

Research Sponsored by Anup Kasi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For cohort 1: Resectable Pancreatic Cancer: No evidence of distant metastasis and tumor mass showing no extension to superior mesenteric artery (SMA) and hepatic artery. There must be clear fat plane between SMA and celiac axis. Patent superior mesenteric vein (SMV/portal vein (PV) with no distortion of venous architecture. Please refer to 2021 NCCN PDAC Guidelines

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 1

Must not have

New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG

Known infection with HIV, hepatitis B, or hepatitis C

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is to test the safety of a new combination treatment for pancreatic, colon, and appendiceal cancers.

Who is the study for?

This trial is for adults with certain types of cancer (pancreatic, colon, or appendiceal) who are in good physical condition and have not had other cancer treatments in the past 2 years. They must be able to understand the study and agree to its terms. Pregnant women and those with serious heart conditions or infections are excluded.

What is being tested?

The safety of a new drug combination is being tested: CEND-1 with FOLFIRINOX chemotherapy, with some patients also receiving Panitumumab. The goal is to see how well these drugs work together against specific cancers before surgery.

What are the potential side effects?

Possible side effects include typical reactions from chemotherapy like nausea, fatigue, hair loss, and increased risk of infection. CEND-1 may cause additional unknown side effects due to its novelty.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pancreatic cancer can be surgically removed and hasn't spread far.

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I am fully active or can carry out light work.

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I am eligible for FOLFIRINOX chemotherapy, with or without panitumumab.

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My cancer, originating from the colon or appendix, has spread to the lining of my abdomen.

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My pancreatic cancer is in a stage where surgery might be possible but is complicated.

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I have at least one tumor that can be measured on scans.

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I have been diagnosed with cancer of the pancreas, colon, or appendix.

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I am healthy enough for major abdominal surgery after the study.

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I can provide tissue samples from a previous biopsy or am willing to have one before and during treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe heart issues, recent heart attack, or unstable heart rhythm.

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I have been diagnosed with HIV, hepatitis B, or hepatitis C.

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I am allergic to an ingredient in the study medication.

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I have brain metastases.

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I am not currently using any other cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Drug Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Secondary study objectives

Disease-free survival (DFS)

Overall response rate (ORR)

Overall survival (OS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3 Oligomets Colon CancerExperimental Treatment3 Interventions

Biopsy for tissue immune profile if archived tissue not available. Folfirinox plus Panitumumab (if RAS/BRAF) infusion for 3 cycles followed by a repeat biopsy for a second tissue immune profiling. Folfirinox plus Panitumumab (if RAS/BRAF positive) and CEND1 infusion for 3 cycles. Seventy-two hours after last infusion participant will have surgery.

Group II: Cohort 2 Peritoneal MetsExperimental Treatment3 Interventions

Group III: Cohort 1 Pancreatic CancerExperimental Treatment2 Interventions

Biopsy for tissue immune profile if archived tissue not available. Folfirinox infusion for 3 cycles followed by a repeat biopsy for a second tissue immune profiling. Folfirinox plus CEND1 infusion for 3 cycles. Seventy-two hours after last infusion participant will have surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Panitumumab

2017

Completed Phase 3

~7150

Folfirinox

2018

Completed Phase 3

~760