Biliary Tract CancerPhase 1/2NCT06255262
Durvalumab Combined With Surufatinib as Maintenance Therapy in Patients With Advanced Biliary Tract Cancer
A Phase 1/2 study testing Surufatinib and Durvalumab in people with Biliary Tract Cancer, run by China Medical University, China at 4 sites in China.
Trial summary
A Real-World Study of Durvalumab combined with Surufatinib as maintenance therapy in patients with advanced biliary tract cancer whose disease did not progress after completion of first-line Durvalumab combined with Gemcitabine+cisplatin treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Surufatinib and Durvalumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesChina
- Study dates
- 15 Feb 2024to 31 Dec 2025
- Phase
- Phase 1/2
- 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
- Age: ≥18 years
- Expected survival is more than 3 months (12 weeks)
- Patients with unresectable advanced or metastatic BTC confirmed by histopathological and/or cytological examination， including bile duct epithelial cell carcinoma (intrahepatic or extrahepatic), gallbladder
- Patients received durvalumab plus GemCis as first-line therapy for 4-8 cycles（ Cycles of chemotherapy were determined according to the investigator and safety profile. In addition, durvalumab plus GemCis was considered to be first-line therapy if the patient had received only antineoplastic traditional Chinese medicine or immunomodulatory therapy before treatment ）,without disease progression (i.e., according to the evaluation of RECIST v1.1 CR, PR or SD)
- At enrollment, World Health Organization (WHO) /ECOG performance status (PS) was 0-1
- In the first-line treatment at least 1 RECIST 1.1 standard target lesion (TL)
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- Organs and bone marrow are sufficiently functional, defined as follows:
- Hemoglobin ≥7g/dL Absolute neutrophil count ≥1.5 × 109/L The platelet count was ≥ 90 × 109/L Serum bilirubin ≤2.0 × upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be 2.5 × ULN or less. For patients with liver metastases, ALT and AST should be ≤5 × ULN Creatinine clearance, calculated by means of the Cockcroft-Gault (based on actual body weight) formula or the 24-hour urinary creatinine clearance assay, should be greater than 50 mL /min
- Weight: > 30kg
- Female subjects promised to be nonpregnant before enrollment, had to be nonlactating, and agreed to use highly effective contraception for the duration of the study
- Male patients who had sex with a female partner of potential pregnancy had to use an acceptable method of contraception from screening through the duration of the study and the drug washout period to prevent their partner from becoming pregnant
- Patients voluntarily participated in the trial, signed informed consent, and complied with the agreement, including receiving treatment, regular visits and examinations, and follow-up.
Who cannot join
- Carcinoma of ampulla
- Any evidence of disease, as judged by the investigator（such as severe or uncontrolled systemic disease, including hypertension that is not controlled by drugs, active bleeding disease, active infection, active ILD/ interstitial lung disease, severe chronic gastrointestinal disease related to diarrhea, mental illness/social conditions）, or a history of allogeneic transplantation that was deemed by the investigator to be inappropriate for study participation or to interfere with adherence to the study protocol
- Active or previously documented autoimmune or inflammatory disease, these include inflammatory bowel diseases [such as colitis or Crohn's disease], diverticulitis [except diverticulosis], systemic lupus erythematosus, sarcoid syndrome, Wegener syndrome [granulomatosis with polyangiitis], Graves disease, rheumatoid arthritis, hypophysitis and uveitis. Exceptions to this criterion are made in the following cases:
- Subjects with vitiligo or alopecia ubjects with hypothyroidism (e.g., after Hashimoto's syndrome) whose condition is stable with hormone-replacement therapy Subjects with any chronic skin disease who did not require systemic treatment Subjects who had not had active disease within the previous 5 years could be enrolled, but only after consultation with a study physician Subjects with celiac disease that could be controlled by diet alone Subjects with ≥ grade 2 lymphopenia will be evaluated on a case-by-case basis after consultation a graduate physician.
- A history of other primary malignancies, except for:Malignancies treated with curative treatment, known no active disease for more than 5 years before the first study intervention, and low potential recurrence；Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or lentigo maligna that has received potentially curative treatment；Or carcinoma in situ that has been adequately treated without evidence of disease
- History of meningeal carcinomatosis
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- A history of active primary immunodeficiency
- Active infections, including tuberculosis (clinical assessment, including the clinical history, physical examination and imaging results, and on the basis of the local operation of tuberculosis examination), or human immunodeficiency virus (HIV 1/2 antibody positive)
- Other approved or investigational antiangiogenic tyrosine kinase inhibitors or monoclonal antibodies were received before the initiation of study treatment
- Caused by past anti-tumor treatment for toxic effects (CTCAE>Grade 2), except for alopecia and vitiligo Subjects with ≥ grade 2 neurological disease will be evaluated on a case-by-case basis after consultation with the study physician Subjects who had an unreasonable expectation of worsening irreversible toxicity from treatment with durvalumab had to consult a study physician before they could be enrolled
- Existing medical conditions or history of brain metastases or spinal cord compression (including asymptomatic and adequately treated disease)
- Known allergies or hypersensitivity reactions to any of the study intervention treatments or any of the study intervention treatment excipients
- Any medical, biologic, or hormonal therapy for cancer that was not permitted in the protocol was used concomitantly. At the same time use hormone therapy of tumor related diseases (such as hormone replacement therapy) is acceptable
- Patients had received live attenuated vaccine within 30 days before the first dose of the study intervention. During the study intervention therapy and the last up to 30 days after the drug into the group of patients are not allowed to accept live vaccine inoculation
- Major surgical procedure (investigator-defined) within 28 days before the first dose
- Participants were enrolled in another clinical trial within 30 days before enrollment and received the investigational drug and any concomitant therapy containing the investigational drug
- Any of the following events occurred within 6 months before enrollment: myocardial infarction, severe/unstable angina, coronary/peripheral-artery bypass grafting, congestive heart failure in NYHA class III or IV, stroke, or transient ischemic attack
- Any serious acute or chronic medical condition that would prevent the patient from participating in the study or affect the interpretation of the study results
- Pregnant or lactating women. Pregnancy status was known before enrollment
- Patients of childbearing age (male/female) who do not agree to use an accepted effective method of contraception during the study treatment and for at least 6 months after the completion of the study treatment
- If urine routine test showed urine protein ≥2+ and 24-hour urine protein >1.0g
- Other strong inducers or inhibitors of CYP3A4 were taken within 2 weeks before the first study dose
- Othere conditions that the investigator thought should be excluded
Trial locations and contacts
4 sites in 1 country.
China4 sites
Anshan Cancer Hospital
Anshan, Liaoning, 110001
Li Man, PhD, 86-18504126900, cmu_trial@163.com
Zan Teng, PhD, +862483282312, tengzan@163.com
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 110001
Zhenghua Wang, PhD, +8613840685400, cmu_trial@163.com
Zan Teng, PhD, +862483282312, tengzan@163.com
First Hospital of China Medical University
Shenyang, Liaoning, 110001
Yunpeng Liu, PhD, 86-24-83282312
Zan Teng, PhD, +862483282312, tengzan@163.com
Shenyang Fifth People's Hospital
Shenyang, Liaoning, 110001
Jian Deng, PhD, 86-13940022801, cmu_trial@163.com
Zan Teng, PhD, +862483282312, tengzan@163.com
About this study
Official title: Durvalumab Combined With Surufatinib as Maintenance Therapy in Patients With Advanced Biliary Tract Cancer Whose Disease Did Not Progress After Completion of First-line Durvalumab Combined With Gemcitabine+Cisplatin Treatment
A Real-World Study of Durvalumab combined with Surufatinib as maintenance therapy in patients with advanced biliary tract cancer whose disease did not progress after completion of first-line Durvalumab combined with Gemcitabine+cisplatin treatment.
Read the detailed description
This is a single-arm, multicentre real-world study of Durvalumab combined with Surufatinib as maintenance therapy in patients with advanced biliary tract cancer whose disease did not progress after completion of first-line Durvalumab combined with Gemcitabine+cisplatin treatment.The primary purpose of the study is exploring the efficacy and safety of durvalumab in combination with surufatinib for the maintenance therapy of patients with advanced biliary tract cancer.
- Conditions
- Biliary Tract Cancer
- Being tested
- Surufatinib, Durvalumab
- Keywords
- Maintenance therapy, Durvalumab, Surufatinib
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurufatinibDrug
Also called SULANDA, HMPL-012
(1) Safety introduction phase (6 cases): 250mg, oral, QD,after one cycle of combined treatment, the occurrence of DLT was evaluated: 1) If ≤1person occurs, continue the dose expansion study at that dose level. 2)In the event of DLT> 1, then the dose of surufatinib was adjusted to 200mg，oral，QD,until disease progression or intolerance of toxicity.
(2) Dose expansion phase (24 cases): RP2D, oral, QD,until disease progression or intolerance of toxicity.
DurvalumabDrug
Also called IMFINZI
1500mg, Q4W.iv.every 28 days; until disease progression or intolerance of toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab in combination with surufatinib | Experimental | 1. Safety introduction phase (6 cases)
2. Dose expansion phase (24 cases) Receives: Drug: Surufatinib; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress Free Survival 1 (PFS1)
PFS1 defined as the time from the initiation of first-line treatment to tumor progression or death.
Measured: 2 years
Secondary outcomes (7)
Safety(number and degree of adverse events)
Safety and tolerance assessment will be conducted according to AE with CTCAE grade ≥3, AESI, ADR, AE, imAE and SAE.
Measured: 2 years
Progression-free survival 2 (PFS2)
Defined as the time from the initiation of maintenance therapy to tumor progression or death.
Measured: 2 years
1-year survival rate（OS12）
Defined as the KM estimate of OS at 12 months after the first dose of first-line therapy, OS12 and 95% CI will be summarized using the Kaplan-Meier method.
Measured: 2 years
Objective Response Rate(ORR,investigator-assessed RECIST 1.1/mRECIST)
Defined as the number of patients (%) with at least one CR or PR visit response since first-line therapy. ORR assessments will include data obtained before progression or before the last evaluable assessment in the absence of progression.ORR will be summarized with the use of the Clopper-Pearson (exact) method and expressed as percentages with 95% confidence intervals.
Measured: 2 years
Disease Control Rate(DCR)
Defined as the best objective response rate of CR, PR, or SD according to RECIST 1.1/ mRECIST criteria. The DCR will be analyzed in the same way as ORR.
Measured: 2 years
Duration of Response(DoR)
Defined as the date of first documented response to disease progression or occurrence of death with or without disease progression (i.e., PFS event or censoring date - date of first response +1). The end date of disease response should coincide with the date of progression or death from any cause used for the PFS endpoint. The time to first response was defined as the follow-up date of the first assessment of CR or PR since the initiation of first-line therapy.
Measured: 2 years
Overall Survival(OS)
Defined as the time from the first dose of first-line therapy to death, irrespective of the actual cause of death of the subject. OS for subjects who were still alive at the time of data analysis or lost to follow-up was censored at the last recording date, that is, subjects known to be alive at or before the data analysis cutoff date.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunpeng Liu, China Medical University, China
- Investigators
- Yunpeng Liu, PhD, Principal investigator, First Hospital of China Medical UniversityXiujuan Qu, PhD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255262
- Sponsor's protocol ID
- DOMESTIC
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durvalumab Combined With Surufatinib as Maintenance Therapy in Patients With Advanced Biliary Tract Cancer Whose Disease Did Not Progress After Completion of First-line Durvalumab Combined With Gemcitabine+Cisplatin Treatment
- ClinicalTrials.gov ID
- NCT06255262
- Acronym / sponsor ID
- DOMESTIC
- Conditions
- Biliary Tract Cancer
- Keywords
- Maintenance therapy, Durvalumab, Surufatinib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Feb 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.
A Real-World Study of Durvalumab combined with Surufatinib as maintenance therapy in patients with advanced biliary tract cancer whose disease did not progress after completion of first-line Durvalumab combined with Gemcitabine+cisplatin treatment.
Detailed description
This is a single-arm, multicentre real-world study of Durvalumab combined with Surufatinib as maintenance therapy in patients with advanced biliary tract cancer whose disease did not progress after completion of first-line Durvalumab combined with Gemcitabine+cisplatin treatment.The primary purpose of the study is exploring the efficacy and safety of durvalumab in combination with surufatinib for the maintenance therapy of patients with advanced biliary tract cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab in combination with surufatinib | Experimental | Drug: Surufatinib, Drug: Durvalumab1. Safety introduction phase (6 cases) 2. Dose expansion phase (24 cases) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age: ≥18 years
- Expected survival is more than 3 months (12 weeks)
- Patients with unresectable advanced or metastatic BTC confirmed by histopathological and/or cytological examination， including bile duct epithelial cell carcinoma (intrahepatic or extrahepatic), gallbladder
- Patients received durvalumab plus GemCis as first-line therapy for 4-8 cycles（ Cycles of chemotherapy were determined according to the investigator and safety profile. In addition, durvalumab plus GemCis was considered to be first-line therapy if the patient had received only antineoplastic traditional Chinese medicine or immunomodulatory therapy before treatment ）,without disease progression (i.e., according to the evaluation of RECIST v1.1 CR, PR or SD)
- At enrollment, World Health Organization (WHO) /ECOG performance status (PS) was 0-1
Key exclusion criteria (23 listed)
- Carcinoma of ampulla
- Any evidence of disease, as judged by the investigator（such as severe or uncontrolled systemic disease, including hypertension that is not controlled by drugs, active bleeding disease, active infection, active ILD/ interstitial lung disease, severe chronic gastrointestinal disease related to diarrhea, mental illness/social conditions）, or a history of allogeneic transplantation that was deemed by the investigator to be inappropriate for study participation or to interfere with adherence to the study protocol
- Active or previously documented autoimmune or inflammatory disease, these include inflammatory bowel diseases [such as colitis or Crohn's disease], diverticulitis [except diverticulosis], systemic lupus erythematosus, sarcoid syndrome, Wegener syndrome [granulomatosis with polyangiitis], Graves disease, rheumatoid arthritis, hypophysitis and uveitis. Exceptions to this criterion are made in the following cases:
- Subjects with vitiligo or alopecia ubjects with hypothyroidism (e.g., after Hashimoto's syndrome) whose condition is stable with hormone-replacement therapy Subjects with any chronic skin disease who did not require systemic treatment Subjects who had not had active disease within the previous 5 years could be enrolled, but only after consultation with a study physician Subjects with celiac disease that could be controlled by diet alone Subjects with ≥ grade 2 lymphopenia will be evaluated on a case-by-case basis after consultation a graduate physician.
- A history of other primary malignancies, except for:Malignancies treated with curative treatment, known no active disease for more than 5 years before the first study intervention, and low potential recurrence；Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or lentigo maligna that has received potentially curative treatment；Or carcinoma in situ that has been adequately treated without evidence of disease
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 |
|---|---|---|
| SurufatinibAlso: SULANDA, HMPL-012(1) Safety introduction phase (6 cases): 250mg, oral, QD,after one cycle of combined treatment, the occurrence of DLT was evaluated: 1) If ≤1person occurs, continue the dose expansion study at that dose level. 2)In the event of DLT> 1, then the dose of surufatinib was adjusted to 200mg，oral，QD,until disease progression or intolerance of toxicity. (2) Dose expansion phase (24 cases): RP2D, oral, QD,until disease progression or intolerance of toxicity. | Drug | Durvalumab in combination with surufatinib |
| DurvalumabAlso: IMFINZI1500mg, Q4W.iv.every 28 days; until disease progression or intolerance of toxicity. | Drug | Durvalumab in combination with surufatinib |
Primary outcome
Progress Free Survival 1 (PFS1)
Time frame: 2 years
PFS1 defined as the time from the initiation of first-line treatment to tumor progression or death.
7 secondary outcomes
Safety(number and degree of adverse events)
Time frame: 2 years
Progression-free survival 2 (PFS2)
Time frame: 2 years
1-year survival rate（OS12）
Time frame: 2 years
Objective Response Rate(ORR,investigator-assessed RECIST 1.1/mRECIST)
Time frame: 2 years
Disease Control Rate(DCR)
Time frame: 2 years
Duration of Response(DoR)
Time frame: 2 years
Overall Survival(OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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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.
Yunpeng Liu, PhD principal investigator
First Hospital of China Medical University
Xiujuan Qu, PhD principal investigator
First Hospital of China Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Surufatinib and Durvalumab in people with Biliary Tract Cancer, run by China Medical University, China 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 12 inclusion and 23 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 13 Feb 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Yunpeng Liu, PhD (86-24-83282312, cmu_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress Free Survival 1 (PFS1) (time frame: 2 years). 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 13 Feb 2024.