Colorectal NeoplasmsPhase 2AGCRC-013NCT01993472
Study of Andrographolides With or Without Capecitabine to Treat Colorectal Cancer
A Phase 2 study testing Andrographolides and Capecitabine in people with Colorectal Neoplasms, run by Gu Yanhong at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of Andrographolides combined with Capecitabine in treatment of elderly patients with locally advanced or recurrent or metastasis inoperable colorectal cancer Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Andrographolides and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Dec 2016
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum
- Locally advanced or recurrent or metastasis inoperable disease
- At least 1 measurable or non-measurable lesion per RECIST version 1.1 guidelines. Lesion must not be chosen from a previously irradiated field unless there had been documented tumor progression in that lesion prior to randomization. All sites of disease must be evaluated ≤ 28 days prior to randomization.
- Man or woman ≥ 65 years of age
- Hematological function, as follow: (≤ 10 days prior to randomization)
- Absolute neutrophil count (ANC) ≥ 1.5×109/L
Show all 15Show fewer
- Platelet count ≥ 75×109/L
- Hemoglobin ≥ 8.0 g/dL
- Renal function, as follows: (≤ 10 days prior to randomization)
- Creatinine≤ 1.5×ULN
- Hepatic function, as follow: (≤ 10 days prior to randomization)
- Aspartate aminotransferase (AST) ≤ 3×ULN(if liver metastases≤ 5×ULN )
- Alanine aminotransferase (ALT) ≤ 3×ULN(if liver metastases≤ 5×ULN )
- Total bilirubin≤ 1.5×ULN
- Subject or subject's legally acceptable representative has provided informed consent
Who cannot join
- Symptomatic brain metastases requiring treatment
- History of other malignancy, except:
- Malignancy treated with curative intent and with no known active disease present for ≥ 5 years prior to randomization and felt to be at low risk for recurrence by the treating physician
- Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
- Adequately treated cervical carcinoma in situ without evidence of disease
- Prostatic intraepithelial neoplasia without evidence of prostate cancer
Show all 13Show fewer
- Antitumor therapy(eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) ≤ 21 days before randomization. Subjects must have recovered from any acute radiotherapy-related toxicity
- Radiotherapy≤ 14 days before randomization. Subjects must have recovered from any acute radiotherapy-related toxicities
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)≤ 6 months prior to randomization
- History of interstitial lung disease(ILD) eg, interstitial pneumonitis, pulmonary fibrosis or evidence of ILD on baseline chest CT or MRI
- History of any medical or psychiatric condition or labortory abnomality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product administration or may interfere with the interpretation of the results
- Unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic event ≤ 30 days before randomization. If on anticoagulation, subject must be on stable therapeutic dose prior to rangdomization.
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures or is unwilling or unable to comply with study requirements
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: Andrographolides With or Without Capecitabine for Elderly Patients With Locally Advanced or Recurrent or Metastasis Inoperable Colorectal Cancer: a Randomized, Open-label Trial.
The purpose of this study is to determine the efficacy and safety of Andrographolides combined with Capecitabine in treatment of elderly patients with locally advanced or recurrent or metastasis inoperable colorectal cancer
- Conditions
- Colorectal Neoplasms
- Being tested
- Andrographolides, Capecitabine
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndrographolidesDrug
Also called xiyanpingzhusheye
comparison of efficacy of Andrographolides combined with Capecitabine or Capecitabine alone in treatment of colorectal cancer
CapecitabineDrug
Also called Xeloda
| Study group | Role | What they receive |
|---|---|---|
| Andrographolides with Capecitabine | Experimental | Capecitabine1250mg/m2 , bid，d1-14，q3w, Andrographolides 500mg，qd，d1-14，q3w; Receives: Drug: Andrographolides; Drug: Capecitabine |
| Capecitabin alone | Active comparator | Capecitabine1250mg/m2 , bid，d1-14，q3w, Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Measured: From date of randomization until the date of first documented progression，assessed up to 100 months
Secondary outcomes (3)
overall survival
Measured: From date of randomization until the date of death from any cause，assessed up to 100 months
Response Rate
Measured: From date of randomization until the date of first documented partial response or complete response, assessed up to 100 months
Quality of Life
Measured: From date of randomization until the date of death from any cause，assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: low accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gu Yanhong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gu Yanhong, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993472
- Sponsor's protocol ID
- AGCRC-013
- Other IDs
- ANDRO-JSPPH-2013
- Acronym
- AGCRC-013
- Status last verified
- Jan 2020
- First submitted
- 12 Nov 2013
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bruchard M, Mignot G, Derangere V, Chalmin F, Chevriaux A, Vegran F, Boireau W, Simon B, Ryffel B, Connat JL, Kanellopoulos J, Martin F, Rebe C, Apetoh L, Ghiringhelli F. Chemotherapy-triggered cathepsin B release in myeloid-derived suppressor cells activates the Nlrp3 inflammasome and promotes tumor growth. Nat Med. 2013 Jan;19(1):57-64. doi: 10.1038/nm.2999. Epub 2012 Dec 2.
PubMed 23202296
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Andrographolides With or Without Capecitabine for Elderly Patients With Locally Advanced or Recurrent or Metastasis Inoperable Colorectal Cancer: a Randomized, Open-label Trial.
- ClinicalTrials.gov ID
- NCT01993472
- Acronym / sponsor ID
- AGCRC-013 / AGCRC-013
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual rate
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Gu YanhongUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Nov 2013 (estimated)
- 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 purpose of this study is to determine the efficacy and safety of Andrographolides combined with Capecitabine in treatment of elderly patients with locally advanced or recurrent or metastasis inoperable colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Andrographolides with Capecitabine | Experimental | Drug: Andrographolides, Drug: CapecitabineCapecitabine1250mg/m2 , bid，d1-14，q3w, Andrographolides 500mg，qd，d1-14，q3w; |
| Capecitabin alone | Active comparator | Drug: CapecitabineCapecitabine1250mg/m2 , bid，d1-14，q3w, |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum
- Locally advanced or recurrent or metastasis inoperable disease
- At least 1 measurable or non-measurable lesion per RECIST version 1.1 guidelines. Lesion must not be chosen from a previously irradiated field unless there had been documented tumor progression in that lesion prior to randomization. All sites of disease must be evaluated ≤ 28 days prior to randomization.
- Man or woman ≥ 65 years of age
- Hematological function, as follow: (≤ 10 days prior to randomization)
Key exclusion criteria (13 listed)
- Symptomatic brain metastases requiring treatment
- History of other malignancy, except:
- Antitumor therapy(eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) ≤ 21 days before randomization. Subjects must have recovered from any acute radiotherapy-related toxicity
- Radiotherapy≤ 14 days before randomization. Subjects must have recovered from any acute radiotherapy-related toxicities
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)≤ 6 months prior to randomization
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 |
|---|---|---|
| AndrographolidesAlso: xiyanpingzhusheyecomparison of efficacy of Andrographolides combined with Capecitabine or Capecitabine alone in treatment of colorectal cancer | Drug | Andrographolides with Capecitabine |
| CapecitabineAlso: Xeloda | Drug | Andrographolides with Capecitabine, Capecitabin alone |
Primary outcome
Progression free survival (PFS)
Time frame: From date of randomization until the date of first documented progression，assessed up to 100 months
3 secondary outcomes
overall survival
Time frame: From date of randomization until the date of death from any cause，assessed up to 100 months
Response Rate
Time frame: From date of randomization until the date of first documented partial response or complete response, assessed up to 100 months
Quality of Life
Time frame: From date of randomization until the date of death from any cause，assessed up to 100 months
Results and safety
The study was stopped early (reason given: low accrual rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Background: PubMed 23202296Bruchard M, Mignot G, Derangere V, Chalmin F, Chevriaux A, Vegran F, Boireau W, Simon B, Ryffel B, Connat JL, Kanellopoulos J, Martin F, Rebe C, Apetoh L, Ghiringhelli F. Chemotherapy-triggered cathepsin B release in myeloid-derived suppressor cells activates the Nlrp3 inflammasome and promotes tumor growth. Nat Med. 2013 Jan;19(1):57-64. doi: 10.1038/nm.2999. Epub 2012 Dec 2.
Related trials for Colorectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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 study testing Andrographolides and Capecitabine in people with Colorectal Neoplasms, run by Gu Yanhong 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 15 inclusion and 13 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: stopped early, as of the sponsor's last update on 14 Jan 2020. 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 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 stopped early (reason given: low accrual rate). Results are not available in the source record.
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?
Progression free survival (PFS) (time frame: From date of randomization until the date of first documented progression，assessed up to 100 months). 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 NCT01993472, which also lists 1 linked publication.
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 14 Jan 2020.