Advanced Intestinal CancerPhase 2/3NCT03350490
Bioinformation Therapy for Intestinal Cancer
A Phase 2/3 study testing Cancer ablation and Life information rehabilitation therapy in people with Advanced Intestinal Cancer, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial summary
The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable intestinal cancer. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Advanced Intestinal Cancer
- What is being tested?
- Cancer ablation and Life information rehabilitation therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2017to 30 Nov 2018
- Phase
- Phase 2/3
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies
- Body tumor 1-6, with at least one tumor length > 2 cm
- KPS ≥ 70, lifespan ：3 - 6 months
- Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L
Who cannot join
- Patients with cardiac pacemaker
- Patients with brain metastasis
- Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site
Fuda cancer institute of Fuda cancer hospital
Guangzhou, Guangdong, 510665
About this study
Official title: Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Intestinal Cancer
The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable intestinal cancer.
Read the detailed description
By enrolling patients with unresectable intestinal cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
- Conditions
- Advanced Intestinal Cancer
- Being tested
- Cancer ablation, Life information rehabilitation therapy
- Keywords
- Cancer ablation, Life information rehabilitation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer ablationDevice
Also called Cryoablation or irreversible electroporation
Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.
Life information rehabilitation therapyDrug
Also called "Qilisheng" Immunoregulatory Oral Solution
Each treatment: one bottle solution each day, consecutive 3 months, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Cancer ablation | Active comparator | In this group, the patients will receive ablation therapy (e.g. cryosurgery or irreversible electroporation) first for big tumors (> 2 cm). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). Receives: Device: Cancer ablation |
| Life information rehabilitation therapy | Active comparator | In this group, the patients will drink "Qilisheng" Immunoregulatory Oral Solution for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). Receives: Drug: Life information rehabilitation therapy |
| Combination therapy | Experimental | In this group,the patients will receive combination therapy,including ablation and life information rehabilitation therapy.They will receive ablation therapy(e.g. cryosurgery or irreversible electroporation)first for big tumors(>2cm),then drink "Qilisheng"Immunoregulatory Oral Solution for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). Receives: Device: Cancer ablation; Drug: Life information rehabilitation therapy |
| Control | No intervention | In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief degree of tumors
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Measured: 3 months
Secondary outcomes (2)
Progress free survival（PFS）
The duration between treatment and cancer recurrence
Measured: 1 year
Overall survival（OS）
The duration between treatment and patient pass way
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start30 Nov 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Intestinal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Shengxin Biotechnology Institute, Beijing
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350490
- Sponsor's protocol ID
- Bioinformation-intestinal
- Status last verified
- Nov 2017
- First submitted
- 19 Nov 2017
- Last updated
- 25 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Intestinal Cancer
- ClinicalTrials.gov ID
- NCT03350490
- Acronym / sponsor ID
- Bioinformation-intestinal
- Conditions
- Advanced Intestinal Cancer
- Keywords
- Cancer ablation, Life information rehabilitation therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Collaborators
- Shengxin Biotechnology Institute, Beijing
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable intestinal cancer.
Detailed description
By enrolling patients with unresectable intestinal cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cancer ablation | Active comparator | Device: Cancer ablationIn this group, the patients will receive ablation therapy (e.g. cryosurgery or irreversible electroporation) first for big tumors (> 2 cm). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
| Life information rehabilitation therapy | Active comparator | Drug: Life information rehabilitation therapyIn this group, the patients will drink "Qilisheng" Immunoregulatory Oral Solution for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
| Combination therapy | Experimental | Device: Cancer ablation, Drug: Life information rehabilitation therapyIn this group,the patients will receive combination therapy,including ablation and life information rehabilitation therapy.They will receive ablation therapy(e.g. cryosurgery or irreversible electroporation)first for big tumors(>2cm),then drink "Qilisheng"Immunoregulatory Oral Solution for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
| Control | No intervention | –In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies
- Body tumor 1-6, with at least one tumor length > 2 cm
- KPS ≥ 70, lifespan ：3 - 6 months
- Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L
Key exclusion criteria (3 listed)
- Patients with cardiac pacemaker
- Patients with brain metastasis
- Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cancer ablationAlso: Cryoablation or irreversible electroporationTumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound. | Device | Cancer ablation, Combination therapy |
| Life information rehabilitation therapyAlso: "Qilisheng" Immunoregulatory Oral SolutionEach treatment: one bottle solution each day, consecutive 3 months, oral administration | Drug | Combination therapy, Life information rehabilitation therapy |
Primary outcome
Relief degree of tumors
Time frame: 3 months
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
2 secondary outcomes
Progress free survival（PFS）
Time frame: 1 year
Overall survival（OS）
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cancer ablation and Life information rehabilitation therapy in people with Advanced Intestinal Cancer, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relief degree of tumors (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2019.