Biliary Tract NeoplasmsNCT04856761
A Study of Capecitabine Versus S-1 as Adjuvant Therapy in Patients With Biliary Tract Carcinoma After Surgical Resection
An observational study of Biliary Tract Neoplasms and Recurrence, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to assess the difference of safety and efficacy about Capecitabine and S-1 for treatment of patients with low-risk of recurrence after BTC surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Neoplasms, Recurrence, Cholangiocarcinoma
- What is being tested?
- S-1 and Capecitabine
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 30 Dec 2024
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients have received curative surgery of pathological diagnosed gallbladder cancer or bile duct cancer.
Who may be able to join
- Male or female, age> 18 years old, and <75 years old.
- Diagnosis is gallbladder cancer or biliary adenocarcinoma via pathological histology.
- Patients have received curative surgery of gallbladder cancer or bile duct cancer, and postoperative pathology has confirmed R0 / R1 resection.
- Ability to comply with the study protocol, in the investigator's judgment.
- No tumor recurrence before the start of chemotherapy.
- No fluorouracil drugs were used in the past six months.
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- The main organ function is good, that is, within 14 days before the start of medication, laboratory inspection confirmed that there is sufficient bone marrow function, liver function, renal function, heart function: hemoglobin ≥90g / L; neutral granulocyte count ≥1.5 × 109 / L; platelet ≥ 70 × 109 / L; alt, AST ≤ 3 × ULN (normal value upper limit); total bilirubin ≤ 2.5 × ULN (normal value upper limit)); serum creatinine <1.5 × ULN (normal value upper limit); Serum albumin ≥ 30g / L; coagulation function: PT extended <2s.
- ECOG score <2.
- Signed Informed Consent Form.
- Male and female subjects with potential fertility must agree to adopt high-efficiency contraceptive methods during the study of at least 3 months after receiving the last treatment.
Who cannot join
- First chemotherapy start time > 16 postoperatively weeks.
- Patients with other tumors, or patients with recurrence before chemotherapy;
- History of allergic with study drugs;
- History of organ transplantation requires immunosuppressive treatment;
- Pregnancy or lactation women;
- Accept the following system treatment within 4 weeks before the start of treatment: cytotoxic treatment, signal conduction inhibitors, immunotherapy, hormone therapy.
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- Participate in other clinical trials within 3 months;
- Abnormality of the peripheral nervous system (> NCI CTC 1), clinically significant mental abnormalities, have a history of abnormal history of the central nervous system;
- Electrocardiogram abnormal or clinically obvious heart disease, such as: congestive heart failure, symptomatic coronary heart disease, arrhythmia, clinical manifestations of heart disease, or epasus in the past 12 months; severe infection (> GRADE 2 National Cancer Institute [NCI] -Common Terminology Criteria for AdverSe Events [CTCAE] Version 3.0), sepsis, severe metabolism or diabetes; Digestive ulcer activity period requires treatment, absorption disabilities, diarrhea, intestinal obstruction , Destroyer of the upper deactivated tract integrity;
- History of HIV infection;
- Anti-viral treatment cannot be controlled or chronic hepatitis C;
- Renal failure requires blood or peritoneal dialysis;
- There are some other serious or unstable diseases or medical, social, sychological states, can endanger the safety of the subject and / or his / her to study the compliance or can prevent patients to participate in clinical research or The assessment of the research results;
- Refused follow-up in accordance with the requirements set by this research program, as well as refused to sign informed consent.
- Other factors that may affect patient income and assessment results;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan hospital
Shanghai, 200040
Lu Lu, MD, 862152887175, lulu@huashan.org.cn
About this study
Official title: A Phase II, Open-Label Study of Capecitabine Versus S-1 as Adjuvant Therapy in Patients With Biliary Tract Carcinoma After Surgical Resection
The purpose of this study is to assess the difference of safety and efficacy about Capecitabine and S-1 for treatment of patients with low-risk of recurrence after BTC surgery.
Read the detailed description
Patients received curative BTC surgery will be informed about the study. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be observed for recurrence of BTC.
- Being tested
- S-1, Capecitabine
- Medical subject headings
- Biliary Tract Neoplasms, Recurrence, Cholangiocarcinoma, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
Also called Tegafur
S-1 was administered at a dose of 80-120 mg/day on 14 days of a tri-weekly cycle for 8 cycles.
CapecitabineDrug
Also called XELODA
Capecitabine was administered at a dose of 1250 mg/m² bid on 14 days of a tri-weekly cycle for 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Cape Group | In this group, capecitabine was administered at a dose of 1250 mg/m² bid on 14 days of a tri-weekly cycle for 8 cycles. Receives: Drug: Capecitabine | |
| S-1 Group | In this group, S-1 was administered at a dose of 80-120 mg/day on 14 days of a tri-weekly cycle for 8 cycles. Receives: Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
RFS, recurrence-free survival
RFS was counted from the enrollment to the date on which disease progression or death was detected, or was censored on the last date when progression-free status was confirmed.
Measured: Enrollment to 1 year
Secondary outcomes (1)
OS, overall survival
OS was calculated from the enrollment to the date of death, or censored on the date of last contact for surviving patients.
Measured: Enrollment 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 posted23 Apr 2021
- Study start1 Nov 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lunxiu Qin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856761
- Sponsor's protocol ID
- HUASHAN005
- Status last verified
- Aug 2022
- First submitted
- 22 Apr 2021
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label Study of Capecitabine Versus S-1 as Adjuvant Therapy in Patients With Biliary Tract Carcinoma After Surgical Resection
- ClinicalTrials.gov ID
- NCT04856761
- Acronym / sponsor ID
- HUASHAN005
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 23 Apr 2021 (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 purpose of this study is to assess the difference of safety and efficacy about Capecitabine and S-1 for treatment of patients with low-risk of recurrence after BTC surgery.
Detailed description
Patients received curative BTC surgery will be informed about the study. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be observed for recurrence of BTC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cape Group | – | Drug: CapecitabineIn this group, capecitabine was administered at a dose of 1250 mg/m² bid on 14 days of a tri-weekly cycle for 8 cycles. |
| S-1 Group | – | Drug: S-1In this group, S-1 was administered at a dose of 80-120 mg/day on 14 days of a tri-weekly cycle for 8 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients have received curative surgery of pathological diagnosed gallbladder cancer or bile duct cancer.
Key inclusion criteria (10 listed)
- Male or female, age> 18 years old, and <75 years old.
- Diagnosis is gallbladder cancer or biliary adenocarcinoma via pathological histology.
- Patients have received curative surgery of gallbladder cancer or bile duct cancer, and postoperative pathology has confirmed R0 / R1 resection.
- Ability to comply with the study protocol, in the investigator's judgment.
- No tumor recurrence before the start of chemotherapy.
Key exclusion criteria (15 listed)
- First chemotherapy start time > 16 postoperatively weeks.
- Patients with other tumors, or patients with recurrence before chemotherapy;
- History of allergic with study drugs;
- History of organ transplantation requires immunosuppressive treatment;
- Pregnancy or lactation 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 |
|---|---|---|
| S-1Also: TegafurS-1 was administered at a dose of 80-120 mg/day on 14 days of a tri-weekly cycle for 8 cycles. | Drug | S-1 Group |
| CapecitabineAlso: XELODACapecitabine was administered at a dose of 1250 mg/m² bid on 14 days of a tri-weekly cycle for 8 cycles. | Drug | Cape Group |
Primary outcome
RFS, recurrence-free survival
Time frame: Enrollment to 1 year
RFS was counted from the enrollment to the date on which disease progression or death was detected, or was censored on the last date when progression-free status was confirmed.
1 secondary outcome
OS, overall survival
Time frame: Enrollment 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 18 Aug 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Neoplasms and Recurrence, run by Fudan University 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 10 inclusion and 15 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 18 Aug 2022. 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.
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?
Contact Haoting Sun, M.D. (13917700105, sunh09@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RFS, recurrence-free survival (time frame: Enrollment to 1 year). 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 18 Aug 2022.