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A Study of PEP503(Radio-enhancer) With Radiotherapy and Chemotherapy for Patients With Rectal Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

A Study of PEP503(Radio-enhancer) With Radiotherapy and Chemotherapy for Patients With Rectal Cancer

A Phase Ib/II Study of PEP503 (Radioenhancer) With Radiotherapy, in Combination With Concurrent Chemotherapy for Patients With Locally Advanced or Unresectable Rectal Cancer

NCT02465593•PharmaEngine

View on ClinicalTrials.gov

Summary

This phase Ib/II study is a prospective, open-label, single arm, nonrandomized study of PEP503(radio-enhancer). There are 2 portions in this study. * Escalation phase (Part Ib): A 3 + 3 dose escalation study design will be adopted in this phase to identify the recommended injection volume of PEP503 for intratumor injection. * Expansion phase (Part II): Following the confirmation of the recommended volume of intratumor injection, 18 additional patients will be enrolled at the recommended volume level to evaluate for efficacy.

Detailed Description

The target population is composed by patients who have confirmed adenocarcinoma of the rectum which is T3-4, N any, or locally unresectable, with tumor distal margin within 10 cm of the anal verge, with no evidence of distant metastatic disease, ECOG performance 0-1, and adequate bone marrow, renal and hepatic function.

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically proven adenocarcinoma of the rectum which is T3-4, N any, or locally unresectable disease , without evidence of distant metastases (M0)
•Distant border of the tumor must be located ≤ 10 cm from the anal verge
•Staging with MRI, transrectal ultrasound or CT-scan to confirm stage and resectability
•ECOG performance 0 - 1
•Age: 20 - 80 years old
•Adequate bone marrow, renal, and hepatic function as:
•* absolute neutrophil count (ANC) ≥ 1,500/mm3
•* platelet count ≥ 100,000/mm3
•* total bilirubin ≤ 1.5x the upper limit of normal (ULN)
•* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN
+3 more criteria

Exclusion Criteria

•Prior history of pelvic radiation therapy
•Hypersensitivity to fluoropyrimidine
•Uncontrolled serious medical or psychiatric illness
•Myocardial infarction or uncontrolled angor pectoris (angina) within the prior 6 months
•No more than 4 weeks since prior participation in any investigational drug study
•Major surgery within 28 days
•Other malignancy within the past 3 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
•Cardiovascular disease that would preclude study treatment or follow-up
•Informed consent not duly signed and dated to participate in the study

Locations (1)

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Key Dates

Start Date

June 1, 2015

Primary Completion Date

July 28, 2021

Completion Date

July 28, 2021

Last Updated

January 11, 2022

Enrollment

ACTUAL participants

Conditions

Rectal Cancer

Interventions

PEP503

DRUG

5-fluorouracil

DRUG

capecitabine

DRUG

surgical resection

PROCEDURE

Radiotherapy

RADIATION

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

NCT04929028

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RECRUITINGPHASE1

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 11, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of PEP503(Radio-enhancer) With Radiotherapy and Chemotherapy for Patients With Rectal Cancer

Inclusion Criteria

Exclusion Criteria

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

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