Metastatic Pancreatic CancerPhase 2NCT01796782
QYHJ Granules Versus Xeloda in Metastatic Pancreatic Cancer
A Phase 2 study testing Xeloda and QYHJ Granules in people with Metastatic Pancreatic Cancer, run by Fudan University.
Trial summary
Primary End Point: To compare the overall survival (OS) using QYHJ Granules or Xeloda as the second therapy in patients with metastatic pancreatic cancer. Secondary End Points: Compare clinical efficacy by other measures including PFS,tumor response,and changes in quality of life (QOL) between these two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Xeloda and QYHJ Granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically/cytologically confirmed metastatic pancreatic adenocarcinoma.
- Patients have failed from the prior chemotherapy without Xeloda. Adjuvant chemotherapy containing Xeloda and 6 months before recruitment is included.
- Patients haven't taken QYHJ Granules before. Prior exposure to Traditional Chinese Medicine not based on QYHJ Formula is allowed provided that at least one week washout time is given prior to initiation of experimental treatment.
- ECOG performance status 0, 1 or 2.
- Measurable disease by RECIST criteria must be present. Bone scan abnormalities alone will not be accepted as measurable disease. Lytic lesions seen on plain radiographs will not be accepted as measurable disease but will be evaluated in conjunction with bone scan abnormalities. Pure blastic bone metastases will not be accepted as measurable disease. Pleural or peritoneal effusions will not be accepted as measurable disease. Irradiated lesions are not considered measurable.
- Patients must not be pregnant. Serum beta-HCG will be checked in all premenopausal patients.
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- Patients must have adequate organ functions reflected by the laboratory criteria below: neutrophil counts ≥ 1.5×109 /L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 85 g/L, Serum creatinine < 2.0 mg/dL, Bilirubin < 1.5 mg/dL, ALT < 3 x normal, albumin >30g/L.
- Age ≥ 18.
- Prior local therapy, e.g., TACE or radiation, is allowed provided that at least 4 weeks washout time is given.
- Concomitant bisphosphonates are allowed for patients with bone metastases. Patients with jaundice must have a biliary drainage decompression operation before recruitment.
- Ability to understand and the willingness to sign a written informed consent.
- Subjects who have a life expectancy of at least 3 months.
Who cannot join
- ECOG performance status 3 or 4.
- Known central nervous system involvement and leptomeningeal disease.
- Previous Xeloda-based chemotherapy （except usage for Adjuvant chemotherapy and 6 months before recruitment）.
- Prior treatment with QYHJ Granules.
- Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV),unstable angina, myocardial infarction within the past six months, severe arrhythmia.
- Concurrent infection requiring intravenous antibiotics, active HIV infection/HIV disease, psychiatric disorders, drug abuse.
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- Known allergies to the QYHJ or Xeloda.
- Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. Men and women of childbearing potential not using effective means of contraception.
- Known other non-adenocarcinoma pathological type.
- Other primary tumour (including primary brain tumours) within the last 5 years prior to enrollment, except for adequately treated carcinoma in situ of the cervix or basal cell skin cancer.
- Inability to take oral medication, prior surgical procedures affecting absorption or unwilling to take the Traditional Chinese Medicine.
- Patiens who are suffering from diarrhea.
- Subjects with poor compliance.
About this study
Official title: A Prospective, Randomized, Open-label, Phase II Study of QYHJ Granules Versus Xeloda in the Second-line Treatment of Patients With Metastatic Pancreatic Cancer
Primary End Point:
- To compare the overall survival (OS) using QYHJ Granules or Xeloda as the second therapy in patients with metastatic pancreatic cancer.
Secondary End Points:
- Compare clinical efficacy by other measures including PFS,tumor response,and changes in quality of life (QOL) between these two groups.
- Examine the feasibility and assess the side effects of treatment using QYHJ Granules in patients with metastatic pancreatic cancer.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Xeloda, QYHJ Granules
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XelodaDrug
Also called Capecitabine
Xeloda dose is calculated according to body surface area.The recommended dose is 1000 mg/m² administered orally twice daily (morning and evening; equivalent to 2000 mg/m² total daily dose) for 2 weeks followed by a 1-week rest period given as 3-week cycles
QYHJ GranulesDrug
1-4 bags bid , days 1-42, every 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Xeloda | Active comparator | Subjects will receive Xeloda until progression Receives: Drug: Xeloda |
| QYHJ Granules | Experimental | patients will receive QYHJ Granules until progression Receives: Drug: QYHJ Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
Measured: up to 3 years
Secondary outcomes (4)
Progression free survival（PFS）
Measured: up to 3 years
Tumor response（ORR、DCR）
Measured: up to 3 years
Clinical benefit rate （CBR）and QOL assessment
Measured: up to 3 years
Number of adverse events of QYHJ Formula
Measured: up to 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 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, liu lu ming, Fudan University
- Investigators
- zhen Chen, M.D., Principal investigator, Fudan Universitylu ming Liu, M.D., Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796782
- Sponsor's protocol ID
- TCM-002
- Status last verified
- Feb 2013
- First submitted
- 16 Dec 2012
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-label, Phase II Study of QYHJ Granules Versus Xeloda in the Second-line Treatment of Patients With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01796782
- Acronym / sponsor ID
- TCM-002
- Conditions
- Metastatic Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 22 Feb 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.
Primary End Point:
- To compare the overall survival (OS) using QYHJ Granules or Xeloda as the second therapy in patients with metastatic pancreatic cancer.
Secondary End Points:
- Compare clinical efficacy by other measures including PFS,tumor response,and changes in quality of life (QOL) between these two groups.
- Examine the feasibility and assess the side effects of treatment using QYHJ Granules in patients with metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xeloda | Active comparator | Drug: XelodaSubjects will receive Xeloda until progression |
| QYHJ Granules | Experimental | Drug: QYHJ Granulespatients will receive QYHJ Granules until progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically/cytologically confirmed metastatic pancreatic adenocarcinoma.
- Patients have failed from the prior chemotherapy without Xeloda. Adjuvant chemotherapy containing Xeloda and 6 months before recruitment is included.
- Patients haven't taken QYHJ Granules before. Prior exposure to Traditional Chinese Medicine not based on QYHJ Formula is allowed provided that at least one week washout time is given prior to initiation of experimental treatment.
- ECOG performance status 0, 1 or 2.
- Measurable disease by RECIST criteria must be present. Bone scan abnormalities alone will not be accepted as measurable disease. Lytic lesions seen on plain radiographs will not be accepted as measurable disease but will be evaluated in conjunction with bone scan abnormalities. Pure blastic bone metastases will not be accepted as measurable disease. Pleural or peritoneal effusions will not be accepted as measurable disease. Irradiated lesions are not considered measurable.
Key exclusion criteria (13 listed)
- ECOG performance status 3 or 4.
- Known central nervous system involvement and leptomeningeal disease.
- Previous Xeloda-based chemotherapy （except usage for Adjuvant chemotherapy and 6 months before recruitment）.
- Prior treatment with QYHJ Granules.
- Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV),unstable angina, myocardial infarction within the past six months, severe arrhythmia.
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 |
|---|---|---|
| XelodaAlso: CapecitabineXeloda dose is calculated according to body surface area.The recommended dose is 1000 mg/m² administered orally twice daily (morning and evening; equivalent to 2000 mg/m² total daily dose) for 2 weeks followed by a 1-week rest period given as 3-week cycles | Drug | Xeloda |
| QYHJ Granules1-4 bags bid , days 1-42, every 6 weeks | Drug | QYHJ Granules |
Primary outcome
overall survival (OS)
Time frame: up to 3 years
4 secondary outcomes
Progression free survival（PFS）
Time frame: up to 3 years
Tumor response（ORR、DCR）
Time frame: up to 3 years
Clinical benefit rate （CBR）and QOL assessment
Time frame: up to 3 years
Number of adverse events of QYHJ Formula
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
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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.
zhen Chen, M.D. principal investigator
Fudan University
lu ming Liu, M.D. study director
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xeloda and QYHJ Granules in people with Metastatic Pancreatic Cancer, run by Fudan University.
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 12 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: status not confirmed, as of the sponsor's last update on 22 Feb 2013. 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?
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?
overall survival (OS) (time frame: up to 3 years). 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 22 Feb 2013; AzTrials last refreshed its copy on 8 Nov 2026.