Gallbladder CancerPhase 2NCT06717464
Toripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer
A Phase 2 study testing Capecitabine and Toripalimab in people with Gallbladder Cancer and Hilar Cholangiocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a randomized controlled study to evaluate the efficacy and safety of toripalimab plus capecitabine as postoperative adjuvant therapy for patients with resectable advanced extrahepatic biliary tract cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallbladder Cancer, Hilar Cholangiocarcinoma, Distal Cholangiocarcinoma
- What is being tested?
- Capecitabine and Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2024to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Both men and women aged ≥18 years old were eligible.
- After radical surgery, postoperative pathological diagnosis of gallbladder cancer and Distal cholangiocarcinoma. TNM staging Ⅱ and above.
- No systemic treatment before to participate in research;
- ECOG PS score 0-1 points;
- The main viscera function is normal, no serious blood, heart, lung, liver, kidney and bone marrow dysfunction, and immune deficiency disease.
- Laboratory tests meet the following requirements: women of childbearing age must be within 14 days before the group for a pregnancy test results were negative serum or urine, and voluntary in the observation period and the last 8 weeks after with the study drug to adopt the appropriate methods of contraception; In men, either surgical sterilization or consent to use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of the study drug was given.
- Patients volunteered for and sign the informed consent;
- Expect good adherence, can according to the plan calls for follow-up curative effect and adverse reactions.
Who cannot join
- Postoperative pathology showed Pancreatic cancer and ampullary cancer;
- The former group received PD 1, PD - L1, PD patients treated L2, CTLA 4, or directly to another stimulus or common weak T cell receptors (such as CTLA - 4, 0 x40, CD137) patients;
- Use of any other study medication within 4 weeks before enrollment;
- Have any active autoimmune disease or a history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (eligible after hormone replacement therapy)); Patients with complete remission of childhood asthma without any intervention in adulthood or with white scarring were eligible, but those requiring medical intervention with bronchodilators were not eligible;
- People with innate or acquired immune deficiency, such as people with human immunodeficiency virus (HIV) infection;
- Patients with uncontrolled cardiac clinical symptoms or diseases, such as unstable angina pectoris with NYHA II or higher heart failure, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
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- Severe infection (e.g., requiring intravenous antibiotics, antifungal, or antiviral drugs) within 4 weeks before the first dose, or unexplained fever >38.5°C during screening/before the first dose;
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Live attenuated vaccine is administered within 4 weeks before the first dose or is planned for the duration of the study;
- Patients with or accompanied by other systemic malignant tumors within the last 5 years (except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and ovarian cancer);
- Known allergy to any of the trial drugs;
- Pregnant, lactating women and subjects with reproductive capacity were unwilling to take effective contraceptive measures;
- Suffering from uncontrollable psychosis; fourteen Other conditions that the investigator deemed inappropriate for inclusion. If the patient has central nervous system metastasis, serious laboratory abnormalities, accompanied by family or social factors, it will affect the safety of the subject, or the collection of data and samples.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: Toripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer, Phase II, Single-center, Randomized Controlled Trial
This is a randomized controlled study to evaluate the efficacy and safety of toripalimab plus capecitabine as postoperative adjuvant therapy for patients with resectable advanced extrahepatic biliary tract cancer.
- Being tested
- Capecitabine, Toripalimab
- Medical subject headings
- Gallbladder Neoplasms, Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
1250mg/m2, D1-D14, q3w, for 24 weeks (8 cycles)
ToripalimabDrug
240mg intravenous injection, q3w, for 54 weeks (18 cycles)
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine therapy group | Experimental | Not described Receives: Drug: Capecitabine |
| Toripalimab combined with capecitabine therapy group | Experimental | Not described Receives: Drug: Capecitabine; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year recurrence-free survival rate
Measured: 1 year
Secondary outcomes (3)
1-year OS
Measured: 1 year
2-year OS
Measured: 2-year
Occurrence of adverse reactions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start12 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- 110 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717464
- Sponsor's protocol ID
- E20241189
- Status last verified
- Oct 2024
- First submitted
- 2 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer, Phase II, Single-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06717464
- Acronym / sponsor ID
- E20241189
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Dec 2024 (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.
This is a randomized controlled study to evaluate the efficacy and safety of toripalimab plus capecitabine as postoperative adjuvant therapy for patients with resectable advanced extrahepatic biliary tract cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine therapy group | Experimental | Drug: Capecitabine |
| Toripalimab combined with capecitabine therapy group | Experimental | Drug: Capecitabine, Drug: Toripalimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Both men and women aged ≥18 years old were eligible.
- After radical surgery, postoperative pathological diagnosis of gallbladder cancer and Distal cholangiocarcinoma. TNM staging Ⅱ and above.
- No systemic treatment before to participate in research;
- ECOG PS score 0-1 points;
- The main viscera function is normal, no serious blood, heart, lung, liver, kidney and bone marrow dysfunction, and immune deficiency disease.
Key exclusion criteria (13 listed)
- Postoperative pathology showed Pancreatic cancer and ampullary cancer;
- The former group received PD 1, PD - L1, PD patients treated L2, CTLA 4, or directly to another stimulus or common weak T cell receptors (such as CTLA - 4, 0 x40, CD137) patients;
- Use of any other study medication within 4 weeks before enrollment;
- Have any active autoimmune disease or a history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (eligible after hormone replacement therapy)); Patients with complete remission of childhood asthma without any intervention in adulthood or with white scarring were eligible, but those requiring medical intervention with bronchodilators were not eligible;
- People with innate or acquired immune deficiency, such as people with human immunodeficiency virus (HIV) infection;
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 |
|---|---|---|
| Capecitabine1250mg/m2, D1-D14, q3w, for 24 weeks (8 cycles) | Drug | Capecitabine therapy group, Toripalimab combined with capecitabine therapy group |
| Toripalimab240mg intravenous injection, q3w, for 54 weeks (18 cycles) | Drug | Toripalimab combined with capecitabine therapy group |
Primary outcome
1-year recurrence-free survival rate
Time frame: 1 year
3 secondary outcomes
1-year OS
Time frame: 1 year
2-year OS
Time frame: 2-year
Occurrence of adverse reactions
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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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 study testing Capecitabine and Toripalimab in people with Gallbladder Cancer and Hilar Cholangiocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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 8 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: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
1-year recurrence-free survival rate (time frame: 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 5 Dec 2024.