Clinical Trials List
Protocol NumberPEP503-RC-1001
2021-06-17 - 2021-12-31
Others
Recruiting3
ICD-10C21.8
Malignant neoplasm of overlapping sites of rectum, anus and anal canal
A Phase Ib/II Study of PEP503 (Radioenhancer) with Radiotherapy, in Combination with Concurrent Chemotherapy for Patients with Locally Advanced or Unresectable Rectal Cancer
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Trial Applicant
PharmaEngine Inc.
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Sponsor
NBTXR3/Nanobiotix
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- CHOU-CHEN CHEN Division of Colorectal Surgery
- YI-CHUN LIU Division of Radiation Therapy
- 趙勇全 Division of Radiation Therapy
- 林俊余 Division of Colorectal Surgery
- 邵彥誠 Division of Colorectal Surgery
- 邱有信 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Pao-Ying Lin Digestive System Department
- Tiong Cheng Digestive System Department
- Long-Sheng Lu Division of Radiation Therapy
- 孔慶惠 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chao-Hung Kuo Digestive System Department
- 黃敬文 Division of Gastroenterological Surgery
- 陳巧雲 Division of Radiology
- Ming-Yii Huang Division of Radiation Therapy
- HSIANG YAO SHIH Digestive System Department
- Huang-Ming Hu Digestive System Department
- Wen-Hung Hsu Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
The pathological diagnosis is confirmed as rectal adenocarcinoma, T3~T4, N any, M0 .The distal boundary of the tumor to the anal opening must be less than or equal to 10 cm.
Objectives
Phase Ib: To evaluate the safety information and recommended dose of PEP5030 in patients with locally advanced rectal cancer who cannot be surgically removed. PEP503 is injected intratumorally, combined with external radiation therapy and chemotherapy.
Phase II: Look at tumor response rate, pathological complete response, pathological response, radical resection rate, one-year local tumor recurrence rate, one-year remote recurrence rate, and one-year disease-free survival rate.
Test Drug
PEP503
Active Ingredient
Hafnium oxide nanoparticle
Dosage Form
Solution
Dosage
64
Endpoints
• Safety assessment: physical examination, vital phenomena, electrocardiogram examination, weight, assessment of daily living ability, clinical numerical assessment (biochemical or hematology), and any adverse reactions, according to the 4.0 version of CTCAE classification
• Effectiveness evaluation: According to RECIST 1.1 to evaluate pathological complete response (pCR), response rate (RR), radical resection rate (R0), one-year local or regional recurrence rate, one-year remote recurrence rate, and One-year disease-free survival
• Assessment of physical kinetic energy test: The concentration of PEP503 in blood or urine will be quantified. The inductively coupled plasma mass spectrometer (ICP-MS) will be used to quantify the concentration of PEP503 in blood or urine.
• Assessment of intratumoral distribution: CT scans are performed before radiotherapy, after treatment, and before tumor resection
• Effectiveness evaluation: According to RECIST 1.1 to evaluate pathological complete response (pCR), response rate (RR), radical resection rate (R0), one-year local or regional recurrence rate, one-year remote recurrence rate, and One-year disease-free survival
• Assessment of physical kinetic energy test: The concentration of PEP503 in blood or urine will be quantified. The inductively coupled plasma mass spectrometer (ICP-MS) will be used to quantify the concentration of PEP503 in blood or urine.
• Assessment of intratumoral distribution: CT scans are performed before radiotherapy, after treatment, and before tumor resection
Inclution 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
- alkaline phosphatase (ALP) ≤ 2.5 x ULN
- calculated creatinine clearance ≥ 50 mL/min, or creatinine within normal range
• All female patients of childbearing potential must have negative urine pregnancy test within the 7 days prior study treatment with PEP503. Patients must agree to use effective contraception during the study
• 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
- alkaline phosphatase (ALP) ≤ 2.5 x ULN
- calculated creatinine clearance ≥ 50 mL/min, or creatinine within normal range
• All female patients of childbearing potential must have negative urine pregnancy test within the 7 days prior study treatment with PEP503. Patients must agree to use effective contraception during the study
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
• 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
The Estimated Number of Participants
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Taiwan
42 participants
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Global
0 participants
