Abscopal Effect for Metastatic Colorectal Cancer

NCT02535988 | Withdrawn Phase 2 DMC

• 1 other identifier: ZhejiangPPH
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with colorectal cancer that had metastatic lesions after been treated with definitive surgery or chemoradiotherapy are being asked to participate in this study.

1. 1.To observe immunity-mediated tumor response outside the radiation field (abscopal effect) after chemoradiotherapy of a metastatic site in metastatic colorectal cancer patients.
2. 2.To induce the efficacy (effectiveness) of a new combination of therapy, chemoradiotherapy and thymalfasin for heavily pretreated, metastatic esophageal cancer patients;
3. 3.To explore the role of PET/CT scanning to assess tumor response/abscopal effect.

Conditions

Colorectal Cancer; Metastatic Colorectal Cancer; Thymalfasin

Keywords

Colorectal Cancer; Metastatic Colorectal Cancer; ZADAXIN; Abscopal Effect; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with an abscopal response assessed at 7-8 weeks after the initiation of treatment.

  week 7- week 8

Secondary Outcomes (2)

• The number of participants with adverse events from the date of enrollment until 2 years from the opening of the study.

  year 0- year 2

• The proportion of patients alive with abscopal responses from the date of enrollment until date of death from any cause, assessed up to 2 years from the opening of the study.

  year 0- year 2

Study Arms (1)

Radiotherapy and Thymalfasin arm

EXPERIMENTAL

Patients with metastatic lesions of colorectal cancer receiving single-agent chemotherapy will receive 3.5 Gy/fraction to a total dose of 35 Gy/10 fractions over 2 weeks with concurrent systemic therapy; Systemic agents are either capecitabine (Xeloda), paclitaxel or S-1;

Radiation: Radiation therapy; Drug: Thymalfasin

Interventions

Radiation therapy RADIATION

3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin for metastatic lesions of colorectal cancer.

Radiotherapy and Thymalfasin arm

Thymalfasin DRUG

Patients with metastatic lesions of colorectal cancer receiving 3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin ( given twice a week with an interval of 3-4 days each week).

Also known as: ZADAXIN's®

Radiotherapy and Thymalfasin arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed colorectal cancer which is persistent and metastatic or recurrent and metastatic;
• Patients must have at least 3 distinct measurable metastatic sites at least 1 cm of larger in their largest diameter;
• Age ≥18 years;
• Metastatic disease measurable on a CT/MRI scan. The primary tumor is not considered measurable disease. Metastatic lesions within a prior radiation field are acceptable as long as disease has progressed in the radiation field by RECIST criteria. The same imaging modality performed at baseline (CT or MRI) will be repeated at subsequent imaging.
• ECOG performance status: 0-1;
• Life expectancy ≥ 3 months.
• Patients have adequate baseline organ and marrow function as defined by an absolute neutrophil count greater than 1500 cells per μL, platelet concentration of greater than 50 000 per μL, total bilirubin less than 1•5 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase less than 2•5 times the ULN, and serum creatinine less than 1•5 times the ULN;
• Signed consent forms voluntarily;

You may not qualify if:

• Patients who have had prior allergic reaction to Apatinib;
• Patients undergoing therapy with other investigational agents.
• Women who are pregnant or breastfeeding;
• Patients with known brain metastases can be included in this clinical trial but brain lesions are not eligible as target or non target lesion;
• Anticipated patient survival under 3 months;
• Active severe infection or known chronic infection with HIV, hepatitis B virus, or hepatitis C virus;
• Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, myocardial infarction, stroke or congestive heart failure within the last 6 months;
• The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
• Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
• Patients with any other concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for participation in the study.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Radiotherapy; Thymalfasin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Study Officials

• Yongshi Jia, MD

  Zhejiang Provincial People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: August 31, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 21, 2023

Record last verified: 2023-09