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Colorectal CancerPhase 2NCT02535988

Abscopal Effect for Metastatic Colorectal Cancer

A Phase 2 study testing Radiation therapy and Thymalfasin in people with Colorectal Cancer and Metastatic Colorectal Cancer, run by Zhejiang Provincial People's Hospital.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. To observe immunity-mediated tumor response outside the radiation field (abscopal effect) after chemoradiotherapy of a metastatic site in… Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Radiation therapy and Thymalfasin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2015to Dec 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
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  • 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.

About this study

Official title: A Phase II Study of Radiotherapy and ZADAXIN's® (Thymalfasin) Induced Abscopal Effect in Patients With Heavily Pretreated, Metastatic Colorectal Cancer

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

This study will help find out what abscopal effects (good or bad) the combination of radiotherapy and thymalfasin has on metastatic esophageal cancer.

Read the detailed description
  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. To induce the efficacy (effectiveness) of a new combination of therapy, chemoradiotherapy and thymalfasin for heavily pretreated, metastatic esophageal cancer patients
  3. To explore the role of PET/CT scanning to assess tumor responses/abscopal effect.

Eligible are patients with metastatic colorectal cancer who have achieved stable disease or have disease progression after systemic therapy (surgery or definitive chemoradiotherapy) and have at least three separate measurable sites of metastatic lesions. Extent of metastatic disease is recorded both at CT and PET/CT scanning. Radiation is given during combined therapy to one of the lesions, 35Gy in 10 fractions over a two week interval, conformally to maximally spare normal tissue or organ. Thymalfasin treatment is given twice a week with an interval of 3-4 days each week. At day 22 radiation is re-started and the same radiation dose is delivered to a second metastatic site, again with thymalfasin. Abscopal response is evaluated by assessing clinical and PET/CT response in the non-irradiated measurable metastatic sites. A Phase II clinical trial based on an optimum two-stage Phase II Simon design is used to conduct this pilot study. Ten patients will be treated in Stage one; if there are no abscopal responses, the trial will be terminated. If there are one or more abscopal responses in Stage One, the trial will proceed to enroll an additional 19 patients.

Being tested
Radiation therapy, Thymalfasin
Keywords
Colorectal Cancer, Metastatic Colorectal Cancer, ZADAXIN, Abscopal Effect, Radiotherapy
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiation therapyRadiation

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

  • ThymalfasinDrug

    Also called ZADAXIN's®

    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).

Study groups in NCT02535988
Study groupRoleWhat they receive
Radiotherapy and Thymalfasin armExperimentalPatients 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;
Receives: Radiation: Radiation therapy; Drug: Thymalfasin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: week 7- week 8

Secondary outcomes (2)

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

    Measured: year 0- year 2

  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.

    Measured: year 0- year 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionJan 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Why it stopped: No recruitment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02535988
Sponsor's protocol ID
ZhejiangPPH
Status last verified
Sep 2023
First submitted
26 Aug 2015
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiation therapy and Thymalfasin in people with Colorectal Cancer and Metastatic Colorectal Cancer, run by Zhejiang Provincial People's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients with an abscopal response assessed at 7-8 weeks after the initiation of treatment. (time frame: week 7- week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02535988.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

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