Pancreatic CancerPhase 2NCT00837239
Huachansu & Gemcitabine in Pancreatic Cancer
A Phase 2 study testing Gemcitabine and HuaChanSu in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in China.
Trial summary
This protocol is part of a larger grant funded by the NCI to create an international research center to study traditional Chinese medicine (TCM). All of the patients enrolled in this study will be treated at the Cancer Hospital, Fudan University, our sister institution in Shanghai, China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gemcitabine and HuaChanSu
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jun 2007to Jul 2012
- 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 unresectable (locally advanced or stage IV) pancreatic adenocarcinoma.
- Karnofsky Performance Status > 60 (see Appendix H for definition)
- 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.
- Patients must have adequate organ functions reflected by the laboratory criteria below: Granulocytes >1,500/uL; Hemoglobin >/= 8.0 gm/dL; Platelets > 100,000/uL; Serum creatinine < 2.0 mg/dL; Bilirubin < 1.5 mg/dL; SGPT < 3 x normal; Alk Phos < 3 x normal; Calcium </=11.0 mg/dL
- Age >/=18
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- Patients must not have received any prior chemotherapy. Prior exposure to Traditional Chinese Medicine is allowed provided that at least one week washout time is given prior to initiation of experimental treatment.
- 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.
- Prior local therapy, e.g., TACE or radiation, is allowed provided that at least 4 weeks washout time is given.
Who cannot join
- Known central nervous system involvement and leptomeningeal disease
- Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV), active HIV infection/HIV disease, psychiatric disorders.
- Known allergies to the huachansu or toad skin products.
- Concurrent infection requiring intravenous antibiotics.
- Pregnant or lactating women.
- Prior treatment with systemic chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled, Blinded Phase II Study of Huachansu & Gemcitabine in Pancreatic Cancer
This protocol is part of a larger grant funded by the NCI to create an international research center to study traditional Chinese medicine (TCM). All of the patients enrolled in this study will be treated at the Cancer Hospital, Fudan University, our sister institution in Shanghai, China. No patients will be seen at MDACC. This protocol will be overseen by the Fudan University Institutional Review Board (IRB00002408) which has Federal Wide Assurance through the U.S. Department of Health \& Human Services (Approved: April 25, 2002). The research nurses have received training at MDACC and will receive regular oversight by MDACC personnel.
Primary End Point:
Read more
- Determine the efficacy of huachansu as measured by progression free survival at 4 months.
Secondary End Points:
- Examine the feasibility and safety of treatment using huachansu in combination with gemcitabine in patients with pancreatic cancer.
- Determine clinical efficacy by other measures including tumor response, 6-month survival, and changes in quality of life (QOL) in patients with pancreatic cancer.
- Monitor patient blood levels of the three main cardiac glycosides that are in huachansu (bufalin, cinobufagin, and resibufogenin). This information will provide evidence to delineate the role of these cardiac glycosides in antitumor activity.
Read the detailed description
The Study Drugs:
HuaChanSu is a substance used in China to treat different types of cancer. One of the major elements of the substance is bufalin, which is an ingredient that has been shown to block the growth of tumor cells.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die.
Screening:
Before you can receive study treatment, you will have "screening tests." These tests will help the study doctor decide if you are eligible to take part in this study. The following tests will be performed:
- You will be asked questions about your medical history and any symptoms you may have now.
- You will have a complete physical exam.
- Your vital signs (temperature, heart rate, breathing rate, and blood pressure), height, and weight will be measured.
- You will be asked how well you are able to perform the normal activities of daily living (a performance status evaluation).
- You will have an electrocardiogram (ECG-a test that measures the electrical activity of the heart).
- To check the status of the cancer, you will have computed tomography (CT) scan(s) and/or magnetic resonance imaging (MRI) scans of your abdomen, pelvis, and any other areas where there is disease.
- You will complete a short questionnaire that will ask questions about your quality of life. This will take about 5 minutes to complete.
- A traditional Chinese medicine diagnosis will also be done. This will include diagnosis by a study doctor. The doctor will take your pulse (heart rate), look at your tongue, and ask you a few questions about your health. The doctor will also use a heart-rate machine and take a photograph of your tongue. This will allow a more scientific check of your heart rate and tongue condition.
- You will have blood (about 3 teaspoons) collected for routine safety tests. This routine blood draw will include a pregnancy test for women who are able to have children. To be eligible to take part in this study, the pregnancy test must be negative.
- You will have 1 biopsy of your tumor tissue to check your cancer type. To collect a tumor tissue biopsy, an area where cancer is located is numbed with anesthetic, and a small amount of tumor tissue is withdrawn through a large needle.
Randomization:
If you are found to be eligible and decide to take part in this study, you may begin treatment.
The first 3 participants enrolled on this study will be given HuaChanSu and gemcitabine, to find out if this dose combination can be tolerated. After the first 3 participants are enrolled, all other participants will be randomly assigned (as in the toss of a coin) to receive HuaChanSu and gemcitabine or gemcitabine and the placebo. The first 20 participants have an equal chance of receiving HuaChanSu or placebo, but after that point, participants will have a better chance of being assigned to the group that is responding better to their study combination. All participants will receive the same dose level of gemcitabine, but you will not know if you are given HuaChanSu or placebo. However, this information can be found out if medically necessary.
Study Treatment:
Before the study drug infusions begin, you will be fitted with a peripherally-inserted central catheter (PICC) by a specially trained nurse. A PICC is a tube that is inserted into a vein, either in your arm or under the collarbone, to make it easier to give you gemcitabine with or without HuaChanSu. This is an outpatient procedure. You will be given a separate consent form for the insertion of the PICC. It will explain the risks of the procedure and how to take care of the PICC. Your doses of gemcitabine and either HuaChanSu or a placebo (a saline [salt water] solution that looks like HuaChanSu but has no effects) will be given through the PICC while you are on this study.
- HuaChanSu (or placebo) will be given as a 2-hour continuous (nonstop) infusion through the PICC. You will receive the 2-hour dose 5 days a week (5 days in a row each time) for 3 weeks. This will be followed by 1 week of not receiving the drug.
- Gemcitabine will be given through a needle in a vein over 30 minutes on Days 1, 8, and 15, followed by 1 week where no study drug is given. Each 4-week treatment period is called a study "cycle."
PK Testing:
During Cycle 1 only, you will have extra blood (about 1 teaspoon each time) collected at various time points for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points. PK blood samples will be drawn 4 times over a 24-hour period on Day 1 and then once each on Days 7, 14, and 21.
Study Tests:
Before each new cycle, you will be asked questions about your current health, and you will have a complete physical exam. Your vital signs and weight will be measured. You will have a performance status evaluation. You will complete a questionnaire about your quality of life. The questionnaire will take about 5 minutes to complete. You will also have blood (about 3 teaspoons) drawn for routine safety tests.
On Days 8 and 15 of each cycle, you will also have blood (about 3 teaspoons) drawn for routine safety tests.
Every 8 weeks (starting in Cycle 3), to check the status of the cancer, you will have CT and/or MRI scan(s) of your abdomen, pelvis, and any other areas where there is disease.
Length of Study Participation:
You may continue to receive more cycles of treatment, as long as the cancer does not get worse and intolerable side effects do not occur.
You will be taken off this study if the cancer gets worse, intolerable side effects occur, new information shows that the treatment is not right for you, you are not able to follow the study rules, the study is stopped, or you decide to leave the study for any reason. If you are thinking about leaving the study, please tell your study doctor, so that you may be told how to end treatment safely as well as what other treatment options are available.
End-of-Treatment Visit:
You will be asked to have a final study visit 4 weeks after your last dose of study drugs. During this visit, you will have the following tests and procedures performed:
- You will have blood (about 3 teaspoons) drawn for routine safety tests.
- You will be asked questions about your medical history.
- You will have a complete physical exam, and your vital signs and weight will be measured.
- You will have a performance status evaluation.
- You will complete a questionnaire about your quality of life.
- To check the status of the cancer, you will have computed tomography (CT) scan(s) and/or magnetic resonance imaging (MRI) scans of your abdomen, pelvis, and any other areas where there is disease (if these were not performed close to the time that you stopped study treatment).
This is an investigational study. HuaChanSu is a commercially available medication that is approved by the Chinese FDA for the treatment of pancreatic cancer. Gemcitabine is approved by the Chinese FDA for the treatment of pancreatic cancer. In this study, the combination of these drugs is being used for research only.
Up to 80 patients will take part in this study. All will be enrolled at Fudan University Cancer Hospital.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine, HuaChanSu, Placebo
- Keywords
- HuaChanSu, HCS, Gastrointestinal, Gastrointestinal Disease, Metastases, Cancer, Pancreatic cancer, Placebo, Gemcitabine, Gemcitabine Hydrocholoride, Gemzar, Fudan UniversityCancer Hospital
- Medical subject headings
- Pancreatic Neoplasms, Gastrointestinal Diseases, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemcitabine Hydrocholoride, Gemzar
1,000 mg/m2 once a week for 3 weeks then 1 week off (28 Day Cycle).
HuaChanSuDrug
Also called HCS
20 mL/m2 for total 500 mL given as a 2 hour infusion, 5 days a week for 3 weeks then one week off (28 Day Cycle).
PlaceboDrug
500 ml saline only administered as a 2 hour infusion by central line.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine + HuaChanSu | Experimental | Gemcitabine 1,000 mg/m2 once a week for 3 weeks then 1 week off + HuaChanSu 20 mL/m2 for total 500 mL given as a 2 hour infusion, 5 days a week for 3 weeks then one week off (28 Day Cycle). Receives: Drug: Gemcitabine; Drug: HuaChanSu |
| Gemcitabine + Placebo | Experimental | Gemcitabine 1,000 mg/m2 once a week for 3 weeks then 1 week off (28 Day Cycle) + Placebo 500 ml saline only administered as a 2 hour infusion by central line. Receives: Drug: Gemcitabine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival at 4 Months
Number of participants without disease progression four months following treatment.
Measured: 4 Months
Secondary outcomes (1)
Median Overall Survival
Median participants overall survival defined as date of study entry until death, or censored to last known date of survival, reported in days.
Measured: Up to 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startJun 2007
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Chris Garrett, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837239
- Sponsor's protocol ID
- 2006-0948
- Status last verified
- Jul 2012
- First submitted
- 3 Feb 2009
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Blinded Phase II Study of Huachansu & Gemcitabine in Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00837239
- Acronym / sponsor ID
- 2006-0948
- Conditions
- Pancreatic Cancer
- Keywords
- HuaChanSu, HCS, Gastrointestinal, Gastrointestinal Disease, Metastases, Cancer, Pancreatic cancer, Placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 5 Feb 2009 (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.
This protocol is part of a larger grant funded by the NCI to create an international research center to study traditional Chinese medicine (TCM). All of the patients enrolled in this study will be treated at the Cancer Hospital, Fudan University, our sister institution in Shanghai, China. No patients will be seen at MDACC. This protocol will be overseen by the Fudan University Institutional Review Board (IRB00002408) which has Federal Wide Assurance through the U.S. Department of Health \& Human Services (Approved: April 25, 2002). The research nurses have received training at MDACC and will receive regular oversight by MDACC personnel.
Primary End Point:
- Determine the efficacy of huachansu as measured by progression free survival at 4 months.
Secondary End Points:
- Examine the feasibility and safety of treatment using huachansu in combination with gemcitabine in patients with pancreatic cancer.
- Determine clinical efficacy by other measures including tumor response, 6-month survival, and changes in quality of life (QOL) in patients with pancreatic cancer.
- Monitor patient blood levels of the three main cardiac glycosides that are in huachansu (bufalin, cinobufagin, and resibufogenin). This information will provide evidence to delineate the role of these cardiac glycosides in antitumor activity.
Detailed description
The Study Drugs:
HuaChanSu is a substance used in China to treat different types of cancer. One of the major elements of the substance is bufalin, which is an ingredient that has been shown to block the growth of tumor cells.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die.
Screening:
Before you can receive study treatment, you will have "screening tests." These tests will help the study doctor decide if you are eligible to take part in this study. The following tests will be performed:
- You will be asked questions about your medical history and any symptoms you may have now.
- You will have a complete physical exam.
- Your vital signs (temperature, heart rate, breathing rate, and blood pressure), height, and weight will be measured.
- You will be asked how well you are able to perform the normal activities of daily living (a performance status evaluation).
- You will have an electrocardiogram (ECG-a test that measures the electrical activity of the heart).
- To check the status of the cancer, you will have computed tomography (CT) scan(s) and/or magnetic resonance imaging (MRI) scans of your abdomen, pelvis, and any other areas where there is disease.
- You will complete a short questionnaire that will ask questions about your quality of life. This will take about 5 minutes to complete.
- A traditional Chinese medicine diagnosis will also be done. This will include diagnosis by a study doctor. The doctor will take your pulse (heart rate), look at your tongue, and ask you a few questions about your health. The doctor will also use a heart-rate machine and take a photograph of your tongue. This will allow a more scientific check of your heart rate and tongue condition.
- You will have blood (about 3 teaspoons) collected for routine safety tests. This routine blood draw will include a pregnancy test for women who are able to have children. To be eligible to take part in this study, the pregnancy test must be negative.
- You will have 1 biopsy of your tumor tissue to check your cancer type. To collect a tumor tissue biopsy, an area where cancer is located is numbed with anesthetic, and a small amount of tumor tissue is withdrawn through a large needle.
Randomization:
If you are found to be eligible and decide to take part in this study, you may begin treatment.
The first 3 participants enrolled on this study will be given HuaChanSu and gemcitabine, to find out if this dose combination can be tolerated. After the first 3 participants are enrolled, all other participants will be randomly assigned (as in the toss of a coin) to receive HuaChanSu and gemcitabine or gemcitabine and the placebo. The first 20 participants have an equal chance of receiving HuaChanSu or placebo, but after that point, participants will have a better chance of being assigned to the group that is responding better to their study combination. All participants will receive the same dose level of gemcitabine, but you will not know if you are given HuaChanSu or placebo. However, this information can be found out if medically necessary.
Study Treatment:
Before the study drug infusions begin, you will be fitted with a peripherally-inserted central catheter (PICC) by a specially trained nurse. A PICC is a tube that is inserted into a vein, either in your arm or under the collarbone, to make it easier to give you gemcitabine with or without HuaChanSu. This is an outpatient procedure. You will be given a separate consent form for the insertion of the PICC. It will explain the risks of the procedure and how to take care of the PICC. Your doses of gemcitabine and either HuaChanSu or a placebo (a saline [salt water] solution that looks like HuaChanSu but has no effects) will be given through the PICC while you are on this study.
- HuaChanSu (or placebo) will be given as a 2-hour continuous (nonstop) infusion through the PICC. You will receive the 2-hour dose 5 days a week (5 days in a row each time) for 3 weeks. This will be followed by 1 week of not receiving the drug.
- Gemcitabine will be given through a needle in a vein over 30 minutes on Days 1, 8, and 15, followed by 1 week where no study drug is given. Each 4-week treatment period is called a study "cycle."
PK Testing:
During Cycle 1 only, you will have extra blood (about 1 teaspoon each time) collected at various time points for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points. PK blood samples will be drawn 4 times over a 24-hour period on Day 1 and then once each on Days 7, 14, and 21.
Study Tests:
Before each new cycle, you will be asked questions about your current health, and you will have a complete physical exam. Your vital signs and weight will be measured. You will have a performance status evaluation. You will complete a questionnaire about your quality of life. The questionnaire will take about 5 minutes to complete. You will also have blood (about 3 teaspoons) drawn for routine safety tests.
On Days 8 and 15 of each cycle, you will also have blood (about 3 teaspoons) drawn for routine safety tests.
Every 8 weeks (starting in Cycle 3), to check the status of the cancer, you will have CT and/or MRI scan(s) of your abdomen, pelvis, and any other areas where there is disease.
Length of Study Participation:
You may continue to receive more cycles of treatment, as long as the cancer does not get worse and intolerable side effects do not occur.
You will be taken off this study if the cancer gets worse, intolerable side effects occur, new information shows that the treatment is not right for you, you are not able to follow the study rules, the study is stopped, or you decide to leave the study for any reason. If you are thinking about leaving the study, please tell your study doctor, so that you may be told how to end treatment safely as well as what other treatment options are available.
End-of-Treatment Visit:
You will be asked to have a final study visit 4 weeks after your last dose of study drugs. During this visit, you will have the following tests and procedures performed:
- You will have blood (about 3 teaspoons) drawn for routine safety tests.
- You will be asked questions about your medical history.
- You will have a complete physical exam, and your vital signs and weight will be measured.
- You will have a performance status evaluation.
- You will complete a questionnaire about your quality of life.
- To check the status of the cancer, you will have computed tomography (CT) scan(s) and/or magnetic resonance imaging (MRI) scans of your abdomen, pelvis, and any other areas where there is disease (if these were not performed close to the time that you stopped study treatment).
This is an investigational study. HuaChanSu is a commercially available medication that is approved by the Chinese FDA for the treatment of pancreatic cancer. Gemcitabine is approved by the Chinese FDA for the treatment of pancreatic cancer. In this study, the combination of these drugs is being used for research only.
Up to 80 patients will take part in this study. All will be enrolled at Fudan University Cancer Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine + HuaChanSu | Experimental | Drug: Gemcitabine, Drug: HuaChanSuGemcitabine 1,000 mg/m2 once a week for 3 weeks then 1 week off + HuaChanSu 20 mL/m2 for total 500 mL given as a 2 hour infusion, 5 days a week for 3 weeks then one week off (28 Day Cycle). |
| Gemcitabine + Placebo | Experimental | Drug: Gemcitabine, Drug: PlaceboGemcitabine 1,000 mg/m2 once a week for 3 weeks then 1 week off (28 Day Cycle) + Placebo 500 ml saline only administered as a 2 hour infusion by central line. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically/cytologically confirmed unresectable (locally advanced or stage IV) pancreatic adenocarcinoma.
- Karnofsky Performance Status > 60 (see Appendix H for definition)
- 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.
- Patients must have adequate organ functions reflected by the laboratory criteria below: Granulocytes >1,500/uL; Hemoglobin >/= 8.0 gm/dL; Platelets > 100,000/uL; Serum creatinine < 2.0 mg/dL; Bilirubin < 1.5 mg/dL; SGPT < 3 x normal; Alk Phos < 3 x normal; Calcium </=11.0 mg/dL
Key exclusion criteria (6 listed)
- Known central nervous system involvement and leptomeningeal disease
- Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV), active HIV infection/HIV disease, psychiatric disorders.
- Known allergies to the huachansu or toad skin products.
- Concurrent infection requiring intravenous antibiotics.
- Pregnant or lactating women.
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 |
|---|---|---|
| GemcitabineAlso: Gemcitabine Hydrocholoride, Gemzar1,000 mg/m2 once a week for 3 weeks then 1 week off (28 Day Cycle). | Drug | Gemcitabine + HuaChanSu, Gemcitabine + Placebo |
| HuaChanSuAlso: HCS20 mL/m2 for total 500 mL given as a 2 hour infusion, 5 days a week for 3 weeks then one week off (28 Day Cycle). | Drug | Gemcitabine + HuaChanSu |
| Placebo500 ml saline only administered as a 2 hour infusion by central line. | Drug | Gemcitabine + Placebo |
Primary outcome
Progression Free Survival at 4 Months
Time frame: 4 Months
Number of participants without disease progression four months following treatment.
1 secondary outcome
Median Overall Survival
Time frame: Up to 4 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 12 Jul 2012.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Chris Garrett, MD principal investigator
UT MD Anderson Cancer Center
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 Gemcitabine and HuaChanSu in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center 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 11 inclusion and 6 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 12 Jul 2012. 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 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?
Progression Free Survival at 4 Months (time frame: 4 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 12 Jul 2012; AzTrials last refreshed its copy on 8 Nov 2026.