Biliary Tract CancerPhase 2ACCORDNCT04333927
Adjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer
A Phase 2 study testing Chemotherapy, Observation and Immunotherapy in people with Biliary Tract Cancer and Extrahepatic Cholangiocarcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The study is a multicenter phase II randomized controlled trial. The purpose is to investigate the efficacy and safety of adjuvant immunotherapy combined with chemoradiation for patients with high-risk resectable extrahepatic cholangiocarcinoma and gallbladder cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Biliary Tract Cancer, Extrahepatic Cholangiocarcinoma, Gallbladder Cancer
- What is being tested?
- Chemotherapy, Observation and Immunotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to Jun 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-70 years;
- Primary resectable extrahepatic cholangiocarcinoma and gallbladder cancer proved by pathology which underwent radical surgery;
- Pathology indicates R0 with T2-4 or N1; or R1;
- ECOG PS 0-1;
- Adequate hematologic, hepatic and renal function: ANC ≥ 1.5x10^9/L, Hb ≥ 80g/L, PLT ≥ 100 x10^9/L, albumin ≥ 28g/L, total bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN, CREA<1.5×ULN;
- At least 6 months of life expectancy.
Who cannot join
- Pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial;
- Received previous anti-cancer therapies;
- With purulent, infected or delayed healed wounds;
- Have risky bleeding events requiring transfusion, operation or local therapies, continuous medication in the past 3 months;
- Have thromboembolism in the past 6 months, including myocardial infarction, unstable angina, stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis;
- Have taken aspirin (>325mg/day) or other antiplatelet drugs continuously for 10 days or more within 2 weeks before enrolment;
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- Uncontrollable hypertension, systolic pressure>140mmHg or diastolic pressure>90mmHg after best medical care, or history of hypertensive crisis or hypertensive encephalopathy;
- Symptomatic congestive heart failure (NYHA class II-IV). Symptomatic or badly-controlled arrhythmia. Congenital long QT syndrome or modified QTc>500ms upon screening;
- Have active autoimmune diseases that require systemic treatment within 2 years before enrolment;
- Active tuberculosis, having antituberculosis therapy at present or within 1 year;
- Have a known history of prior invasive malignancies within 5 years before enrolment;
- Have other uncontrollable comorbidities;
- Infection of HIV, known syphilis requiring treatment;
- Allergic to chemotherapeutics.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Adjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer: a Phase II, Multicenter, Randomized Controlled Trial
The study is a multicenter phase II randomized controlled trial. The purpose is to investigate the efficacy and safety of adjuvant immunotherapy combined with chemoradiation for patients with high-risk resectable extrahepatic cholangiocarcinoma and gallbladder cancer.
Read the detailed description
The trial will recruit 92 patients, and they will be randomized (1:1) into two groups (chemoradiation+immunotherapy group, observation group) after operation. Patients in chemoradiation+immunotherapy group will receive camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal. After 1 or 2 courses of camrelizumab, patients went on to receive capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week) concurrent with radiotherapy (45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed). Patients in observation group will not receive any anti-cancer therapy.
- Being tested
- Chemotherapy, Observation, Immunotherapy, Radiotherapy
- Medical subject headings
- Biliary Tract Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week).
ObservationOther
Patients in observation group will not receive any anti-cancer therapy.
ImmunotherapyProcedure or surgery
Camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal.
RadiotherapyRadiation
45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients in treatment group will receive camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal. After 1 or 2 courses of camrelizumab, patients went on to receive capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week) concurrent with radiotherapy (45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed). Receives: Drug: Chemotherapy; Procedure: Immunotherapy; Radiation: Radiotherapy |
| Observation | Placebo comparator | Patients in observation group will not receive any anti-cancer therapy. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.
Measured: two years
Secondary outcomes (2)
Recurrence-free Survival
defined as the time from randomization until disease recurrence or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and recurrence-free. Patients not having an event will be censored at the date last seen alive.
Measured: two years
Adverse Events
adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start1 Jun 2020
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
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 Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Kuang, Sun Yat-sen University
- Investigators
- Ming Kuang, PhD, Study chair, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333927
- Sponsor's protocol ID
- BTC001
- Acronym
- ACCORD
- Status last verified
- Jun 2020
- First submitted
- 2 Apr 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xiao H, Ji J, Li S, Lai J, Wei G, Wu J, Chen W, Xie W, Wang S, Qiao L, Tu J, Shen S, Peng Z. Adjuvant Chemoradiation and Immunotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Cancer: A Randomized Clinical Trial. JAMA Oncol. 2025 Sep 1;11(9):1021-1029. doi: 10.1001/jamaoncol.2025.1926.
PubMed 40638104
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer: a Phase II, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04333927
- Acronym / sponsor ID
- ACCORD / BTC001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 3 Apr 2020 (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 study is a multicenter phase II randomized controlled trial. The purpose is to investigate the efficacy and safety of adjuvant immunotherapy combined with chemoradiation for patients with high-risk resectable extrahepatic cholangiocarcinoma and gallbladder cancer.
Detailed description
The trial will recruit 92 patients, and they will be randomized (1:1) into two groups (chemoradiation+immunotherapy group, observation group) after operation. Patients in chemoradiation+immunotherapy group will receive camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal. After 1 or 2 courses of camrelizumab, patients went on to receive capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week) concurrent with radiotherapy (45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed). Patients in observation group will not receive any anti-cancer therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Chemotherapy, Procedure: Immunotherapy, Radiation: RadiotherapyPatients in treatment group will receive camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal. After 1 or 2 courses of camrelizumab, patients went on to receive capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week) concurrent with radiotherapy (45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed). |
| Observation | Placebo comparator | Other: ObservationPatients in observation group will not receive any anti-cancer therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18-70 years;
- Primary resectable extrahepatic cholangiocarcinoma and gallbladder cancer proved by pathology which underwent radical surgery;
- Pathology indicates R0 with T2-4 or N1; or R1;
- ECOG PS 0-1;
- Adequate hematologic, hepatic and renal function: ANC ≥ 1.5x10^9/L, Hb ≥ 80g/L, PLT ≥ 100 x10^9/L, albumin ≥ 28g/L, total bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN, CREA<1.5×ULN;
Key exclusion criteria (14 listed)
- Pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial;
- Received previous anti-cancer therapies;
- With purulent, infected or delayed healed wounds;
- Have risky bleeding events requiring transfusion, operation or local therapies, continuous medication in the past 3 months;
- Have thromboembolism in the past 6 months, including myocardial infarction, unstable angina, stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis;
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 |
|---|---|---|
| ChemotherapyCapecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week). | Drug | Treatment |
| ObservationPatients in observation group will not receive any anti-cancer therapy. | Other | Observation |
| ImmunotherapyCamrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal. | Procedure or surgery | Treatment |
| Radiotherapy45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed. | Radiation | Treatment |
Primary outcome
Overall Survival
Time frame: two years
defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.
2 secondary outcomes
Recurrence-free Survival
Time frame: two years
Adverse Events
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Derived from this study: PubMed 40638104Xiao H, Ji J, Li S, Lai J, Wei G, Wu J, Chen W, Xie W, Wang S, Qiao L, Tu J, Shen S, Peng Z. Adjuvant Chemoradiation and Immunotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Cancer: A Randomized Clinical Trial. JAMA Oncol. 2025 Sep 1;11(9):1021-1029. doi: 10.1001/jamaoncol.2025.1926.
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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.
Ming Kuang, PhD study chair
First Affiliated Hospital, Sun Yat-Sen University
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 Chemotherapy, Observation and Immunotherapy in people with Biliary Tract Cancer and Extrahepatic Cholangiocarcinoma, run by Sun Yat-sen 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 6 inclusion and 14 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 23 Jun 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. Some participants in this study may receive a placebo. 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 (time frame: two years). 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 NCT04333927, 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 23 Jun 2020.