Cholangiocarcinoma CancerPhase 2ACHIEVENCT06607276
Phase 2 Trial of Adjuvant Adebrelimab Combined With Capecitabine in High-Risk Resected Cholangiocarcinoma: ACHIEVE
A Phase 2 study testing Adebrelimab and capecitabine and capecitabine in people with Cholangiocarcinoma Cancer and Adebrelimab (SHR-1316), run by The First Affiliated Hospital with Nanjing Medical University at 4 sites in China.
Trial summary
Biliary tract malignancies (BTC) are malignant tumors that originate from the epithelium of the bile ducts. Currently, the optimal treatment for biliary tract malignancies is radical surgical resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma Cancer, Adebrelimab (SHR-1316)
- What is being tested?
- Adebrelimab and capecitabine and capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 4 sitesChina
- Study dates
- 20 Sep 2024to 20 Sep 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must sign an informed consent form;
- Ages 18-75, both genders eligible;
- ECOG performance status score (PS score) of 0 or 1;
- Patients with histologically confirmed cholangiocarcinoma (including intrahepatic cholangiocarcinoma and hilar cholangiocarcinoma), who have undergone R0 resection and have high-risk factors for recurrence;
- High-risk factors are defined as follows:
- Intrahepatic cholangiocarcinoma ( Single tumor > 5 cm, multiple tumors, liver capsule breach, vascular invasion, regional lymph node metastasis) Hilar cholangiocarcinoma (Tumor invasion into surrounding tissues, vascular invasion, regional lymph node metastasis)
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- No evidence of recurrence or metastatic lesions on imaging within 28 days prior to randomization;
- No prior systemic anti-cancer therapy (including radiotherapy, chemotherapy, targeted therapy, immunotherapy) before curative resection;
- Laboratory test values within 7 days prior to the first dose of study medication meet the following criteria:
- Complete blood count: (except for hemoglobin, no blood transfusion or use of granulocyte colony-stimulating factor [G-CSF], no medication correction within 2 weeks prior to screening):
- Absolute neutrophil count ≥1.5×109/L; Platelets ≥75×109/L; Hemoglobin ≥90 g/L;
- Biochemical tests:
- Serum albumin ≥30g/L; Serum total bilirubin ≤1.5×ULN; ALT and AST ≤3×ULN; Serum creatinine ≤1.5×ULN; or Cr clearance rate \>50 mL/min International normalized ratio (INR) ≤1.2 or prothrombin time (PT) exceeding the normal control range by ≤2 seconds; Urine protein \<2+ (if urine protein ≥2+, a 24-hour (h) urine protein quantification can be performed, and a 24h urine protein quantification of \<1.0g is eligible for enrollment);
- Life expectancy of more than 6 months.
Who cannot join
- Pathological diagnosis of mixed hepatocellular carcinoma and other non-hepatic extra-bile duct cholangiocarcinoma or ampulla of Vater malignant tumor components;
- History of prior systemic treatment;
- History of or concurrent other malignancies, excluding non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma that have been adequately treated;
- Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to enrollment; history of active tuberculosis infection more than 1 year prior to enrollment without proper anti-tuberculosis treatment or tuberculosis is still active;
- History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener\'s granulomatosis, Sjogren\'s syndrome, Guillain-Barre syndrome, or multiple sclerosis;
- Requirement for long-term systemic corticosteroids (dosage equivalent to \>10mg prednisone/day) or any other form of immunosuppressive treatment. Subjects using inhaled or topical corticosteroids may be included;
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- Severe cardiopulmonary or renal dysfunction;
- Inadequately controlled arterial hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) (based on the average of ≥2 blood pressure readings), allowing the achievement of the above parameters through the use of antihypertensive treatment; history of hypertensive crisis or hypertensive encephalopathy;
- Within 3 months prior to enrollment, significant clinical bleeding symptoms or a clear tendency to bleed; abnormal coagulation function (PT \>14s), tendency to bleed, or undergoing thrombolytic or anticoagulant therapy;
- HBV DNA \>2000 IU/ml, active HCV infection (positive HCV antibody and HCV-RNA level above the lower limit of detection);
- Active infection requiring systemic treatment;
- Human immunodeficiency virus (HIV, HIV1/2 antibody) positive;
- History of psychiatric medication abuse, alcoholism, or drug addiction;
- History of allergy to study medication;
- Other factors deemed by the investigator to potentially affect subject safety or trial compliance. Such as severe diseases requiring concurrent treatment (including psychiatric diseases), severe laboratory test abnormalities, or other family or social factors.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Not yet recruiting
Jinling Hospital
Nanjing, Jiangsu, 210000
Yuan Cheng, MD, 86 13915963713, 19656093@qq.com
Yuan Cheng, MD
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210002
Changxian Li, MD, 86 18761854602, doclicx20@163.com
Changxian Li, MD
- Not yet recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 240000
Bin Zhang, MD, 86 15252039221, zhangbin209@163.com
Bin Zhang, MD
- Not yet recruiting
Yancheng NO.1 People's Hospital
Yancheng, Jiangsu, 280000
Yonghua X, MD, 86 13912509000, drxuyh@163.com
YOnghua Xu, MD
About this study
Official title: A Phase 2, Randomized, Controlled, Multicenter Study of Adjuvant Adebrelimab Combined With Capecitabine in Resected Cholangiocarcinoma With High-risk Factors: ACHIEVE
Biliary tract malignancies (BTC) are malignant tumors that originate from the epithelium of the bile ducts. Currently, the optimal treatment for biliary tract malignancies is radical surgical resection. In recent years, with the advancement of imaging technology and surgical techniques, there has been certain progress in the diagnosis and treatment of biliary tract malignancies. However, the surgical resection rate and long-term survival rate after surgery are still not satisfactory, and the high postoperative recurrence rate is an important factor affecting the long-term survival of patients. Therefore, there is an urgent need to explore new postoperative adjuvant treatment plans to reduce postoperative tumor recurrence, which is of great significance for extending the survival of patients with biliary tract malignancies. In the NCCN and CSCO guidelines, capecitabine is listed as a category I recommendation for adjuvant treatment of biliary tract malignancies (BTC). However, in clinical practice, the use of capecitabine or tegafur for postoperative patients with cholangiocarcinoma at high risk of recurrence still has a high recurrence rate. Therefore, there is still a huge unmet need in the clinical adjuvant treatment after surgery for biliary tract malignancies. Based on the above background, we plan to carry out a randomized, open, and comparative study to observe the efficacy and safety of Adebrelimab combined with capecitabine for adjuvant treatment in patients with biliary tract malignancies after surgery, and to explore treatment methods to improve the efficacy of postoperative adjuvant treatment for cholangiocarcinoma.
Read the detailed description
Postoperative adjuvant therapy for biliary system tumors has long lacked a universally recognized standard regimen. The BILCAP trial results showed a survival benefit with adjuvant therapy. The BILCAP study filled the gap in the field of postoperative adjuvant therapy for biliary system tumors. In the study, the median overall survival (OS) in the capecitabine group was 51.1 months, compared to 36.4 months in the observation group. The median recurrence-free survival (RFS) in the capecitabine group was 24.4 months, compared to 17.5 months in the observation group. Compared to the observation group, adjuvant therapy with capecitabine significantly prolonged both OS and RFS, and the capecitabine group had good tolerability with no chemotherapy-related deaths. In addition, the ASCOT study reported that adjuvant therapy with tegafur after surgery could prolong the RFS rate in patients. Therefore, in the NCCN and CSCO guidelines, capecitabine is listed as a category I recommendation for adjuvant therapy of biliary tract malignancies (BTC). However, it is regrettable that the latest reports show that in the intention-to-treat (ITT) population, the BILCAP trial failed to reach its primary endpoint of OS, with the median OS in the study group and the control group being 51.1 months and 36.4 months, respectively [HR=0.81, 95% CI(0.63,1.04), P=0.097]. Furthermore, in clinical practice, the use of capecitabine or tegafur after surgery in patients with cholangiocarcinoma at high risk of recurrence still has a high recurrence rate. Therefore, there is still a significant unmet need in the clinical postoperative adjuvant therapy for biliary tract malignancies.Based on the above background, we plan to carry out a randomized, open, and comparative study to observe the efficacy and safety of Adebrelimab combined with capecitabine for adjuvant treatment in patients with biliary tract malignancies after surgery, and to explore treatment methods to improve the efficacy of postoperative adjuvant treatment for cholangiocarcinoma.
- Conditions
- Cholangiocarcinoma Cancer, Adebrelimab (SHR-1316)
- Being tested
- Adebrelimab and capecitabine, capecitabine
- Keywords
- Adebrelimab, capecitabine, Cholangiocarcinoma, Adjuvant Therapy
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab and capecitabineDrug
Adebrelimab: 1200mg, IV, q3w for one year; capecitabine:1250mg/m2, po, bid,d1-14, q3w, for 6-8 cycles
capecitabineDrug
capecitabine:1250mg/m2, po, bid,d1-14, q3w, for 6-8 cycles
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab and capecitabine | Experimental | Not described Receives: Drug: Adebrelimab and capecitabine |
| capecitabine | Active comparator | Not described Receives: Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
one year recurrence free survival rate (1-year RFS)
1-year RFS refers to the proportion of patients who have not experienced disease recurrence or death within one year from randomization.
Measured: 1 year
Secondary outcomes (3)
overall survival (OS)
Overall survival (OS) refers to the length of time from randomization until death from any cause.
Measured: 3 year
Recurrence free survival (RFS)
Recurrence-free survival (RFS) refers to the length of time after randomization during which a patient remains free from the recurrence of the disease.
Measured: 2 year
minimal residual disease (MRD)
MRD refers to tumor-derived molecular abnormalities that are undetectable by imaging or traditional laboratory methods after treatment, but can be identified through liquid biopsy.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start20 Sep 2024
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Sep 2027 (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 Cholangiocarcinoma CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- 122 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jinling Hospital, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607276
- Sponsor's protocol ID
- 2024-SR-571
- Acronym
- ACHIEVE
- Status last verified
- Jan 2025
- First submitted
- 19 Sep 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Publications
Cheng Y, Zhang Y, Li C, Li X. Adebrelimab plus capecitabine versus capecitabine monotherapy for adjuvant treatment of high-risk resected cholangiocarcinoma (ACHIEVE): protocol for a phase II, multicentre, randomised controlled trial. BMJ Open Gastroenterol. 2025 Jul 30;12(1):e001892. doi: 10.1136/bmjgast-2025-001892.
PubMed 40738506
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Controlled, Multicenter Study of Adjuvant Adebrelimab Combined With Capecitabine in Resected Cholangiocarcinoma With High-risk Factors: ACHIEVE
- ClinicalTrials.gov ID
- NCT06607276
- Acronym / sponsor ID
- ACHIEVE / 2024-SR-571
- Conditions
- Cholangiocarcinoma Cancer, Adebrelimab (SHR-1316)
- Keywords
- Adebrelimab, capecitabine, Cholangiocarcinoma, Adjuvant Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jinling Hospital, China
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Sep 2027 (estimated)
- First posted
- 23 Sep 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.
Biliary tract malignancies (BTC) are malignant tumors that originate from the epithelium of the bile ducts. Currently, the optimal treatment for biliary tract malignancies is radical surgical resection. In recent years, with the advancement of imaging technology and surgical techniques, there has been certain progress in the diagnosis and treatment of biliary tract malignancies. However, the surgical resection rate and long-term survival rate after surgery are still not satisfactory, and the high postoperative recurrence rate is an important factor affecting the long-term survival of patients. Therefore, there is an urgent need to explore new postoperative adjuvant treatment plans to reduce postoperative tumor recurrence, which is of great significance for extending the survival of patients with biliary tract malignancies. In the NCCN and CSCO guidelines, capecitabine is listed as a category I recommendation for adjuvant treatment of biliary tract malignancies (BTC). However, in clinical practice, the use of capecitabine or tegafur for postoperative patients with cholangiocarcinoma at high risk of recurrence still has a high recurrence rate. Therefore, there is still a huge unmet need in the clinical adjuvant treatment after surgery for biliary tract malignancies. Based on the above background, we plan to carry out a randomized, open, and comparative study to observe the efficacy and safety of Adebrelimab combined with capecitabine for adjuvant treatment in patients with biliary tract malignancies after surgery, and to explore treatment methods to improve the efficacy of postoperative adjuvant treatment for cholangiocarcinoma.
Detailed description
Postoperative adjuvant therapy for biliary system tumors has long lacked a universally recognized standard regimen. The BILCAP trial results showed a survival benefit with adjuvant therapy. The BILCAP study filled the gap in the field of postoperative adjuvant therapy for biliary system tumors. In the study, the median overall survival (OS) in the capecitabine group was 51.1 months, compared to 36.4 months in the observation group. The median recurrence-free survival (RFS) in the capecitabine group was 24.4 months, compared to 17.5 months in the observation group. Compared to the observation group, adjuvant therapy with capecitabine significantly prolonged both OS and RFS, and the capecitabine group had good tolerability with no chemotherapy-related deaths. In addition, the ASCOT study reported that adjuvant therapy with tegafur after surgery could prolong the RFS rate in patients. Therefore, in the NCCN and CSCO guidelines, capecitabine is listed as a category I recommendation for adjuvant therapy of biliary tract malignancies (BTC). However, it is regrettable that the latest reports show that in the intention-to-treat (ITT) population, the BILCAP trial failed to reach its primary endpoint of OS, with the median OS in the study group and the control group being 51.1 months and 36.4 months, respectively [HR=0.81, 95% CI(0.63,1.04), P=0.097]. Furthermore, in clinical practice, the use of capecitabine or tegafur after surgery in patients with cholangiocarcinoma at high risk of recurrence still has a high recurrence rate. Therefore, there is still a significant unmet need in the clinical postoperative adjuvant therapy for biliary tract malignancies.Based on the above background, we plan to carry out a randomized, open, and comparative study to observe the efficacy and safety of Adebrelimab combined with capecitabine for adjuvant treatment in patients with biliary tract malignancies after surgery, and to explore treatment methods to improve the efficacy of postoperative adjuvant treatment for cholangiocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab and capecitabine | Experimental | Drug: Adebrelimab and capecitabine |
| capecitabine | Active comparator | Drug: capecitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must sign an informed consent form;
- Ages 18-75, both genders eligible;
- ECOG performance status score (PS score) of 0 or 1;
- Patients with histologically confirmed cholangiocarcinoma (including intrahepatic cholangiocarcinoma and hilar cholangiocarcinoma), who have undergone R0 resection and have high-risk factors for recurrence;
- Intrahepatic cholangiocarcinoma ( Single tumor > 5 cm, multiple tumors, liver capsule breach, vascular invasion, regional lymph node metastasis) Hilar cholangiocarcinoma (Tumor invasion into surrounding tissues, vascular invasion, regional lymph node metastasis)
Key exclusion criteria (15 listed)
- Pathological diagnosis of mixed hepatocellular carcinoma and other non-hepatic extra-bile duct cholangiocarcinoma or ampulla of Vater malignant tumor components;
- History of prior systemic treatment;
- History of or concurrent other malignancies, excluding non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma that have been adequately treated;
- Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to enrollment; history of active tuberculosis infection more than 1 year prior to enrollment without proper anti-tuberculosis treatment or tuberculosis is still active;
- History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener\'s granulomatosis, Sjogren\'s syndrome, Guillain-Barre syndrome, or multiple sclerosis;
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 |
|---|---|---|
| Adebrelimab and capecitabineAdebrelimab: 1200mg, IV, q3w for one year; capecitabine:1250mg/m2, po, bid,d1-14, q3w, for 6-8 cycles | Drug | Adebrelimab and capecitabine |
| capecitabinecapecitabine:1250mg/m2, po, bid,d1-14, q3w, for 6-8 cycles | Drug | capecitabine |
Primary outcome
one year recurrence free survival rate (1-year RFS)
Time frame: 1 year
1-year RFS refers to the proportion of patients who have not experienced disease recurrence or death within one year from randomization.
3 secondary outcomes
overall survival (OS)
Time frame: 3 year
Recurrence free survival (RFS)
Time frame: 2 year
minimal residual disease (MRD)
Time frame: 2 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 16 Jan 2025.
- Derived from this study: PubMed 40738506Cheng Y, Zhang Y, Li C, Li X. Adebrelimab plus capecitabine versus capecitabine monotherapy for adjuvant treatment of high-risk resected cholangiocarcinoma (ACHIEVE): protocol for a phase II, multicentre, randomised controlled trial. BMJ Open Gastroenterol. 2025 Jul 30;12(1):e001892. doi: 10.1136/bmjgast-2025-001892.
- Individual participant dataSharing planned: Undecided. undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab and capecitabine and capecitabine in people with Cholangiocarcinoma Cancer and Adebrelimab (SHR-1316), run by The First Affiliated Hospital with Nanjing Medical University at 4 sites 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 14 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: looking for participants now, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Contact Xiangcheng Li, Prof. M.D. (86 18951999088, drlixc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one year recurrence free survival rate (1-year RFS) (time frame: 1 year). 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 NCT06607276, 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 16 Jan 2025.