AzTrials
AzTrials

Advanced Biliary Tract CancerPhase 2NCT06708858

Phase Ⅱ Clinical Study of Surufatinib Combined With Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract Cancer

A Phase 2 study testing Surufatinib, Gemcitabine and Cisplatin in people with Advanced Biliary Tract Cancer, run by Dai, Guanghai at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II trial studies how well gemcitabine, cisplatin and durvalumab/Pembrolizumab and surufatinib work in treating participants with advanced Biliary Tract Cancer. The international multicenter phase III clinical study TOPAZ-1 has confirmed that durvalumab combined with gemcitabine and cisplatin can bring… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Biliary Tract Cancer
What is being tested?
Surufatinib, Gemcitabine and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
15 Aug 2024to Jul 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 with biliary tract cancer who are clearly diagnosed by pathology, are unable to undergo radical surgery or have local/distant metastasis (allowing surgical treatment after successful transformation).
  • Have at least 1 lesion that can be measured according to RECIST v1.1 (more than 1cm on CT or MRI).
  • Have not received systematic anti-tumor therapy before.
  • Expected survival greater than 3 months;
  • Age 18-75 years old, male and female;
  • Body weight > 40kg;
Show all 15Show fewer
  • ECOG 0-1
  • Total peripheral blood white blood cells > 2×109/L;
  • Bone marrow reserve and liver and kidney function (as demonstrated by the following laboratory tests prior to initial treatment) :
  • Neutrophil absolute value ≥ 1,000/mm3; Hemoglobin > 8g/dL; Platelet count > 80,000/mm3; Glutamic pyruvic transaminase/glutamic oxalacetic transaminase < 3×ULN; Serum creatinine < 3×ULN. Total bilirubin level < 3×ULN.
  • No obvious genetic disease;
  • Liver function child-pugh A ;
  • Women of childbearing age (15 to 49 years) must undergo a pregnancy test with a negative result within 7 days before starting treatment and have effective contraception within 120 days after the last cycle of treatment.
  • The previous treatment for the tumor has ended for at least 4 weeks, and the adverse reactions of the previous treatment have basically recovered (according to the CTCAE5.0 standard ≤ Grade 1, except hair loss).
  • Voluntarily enrolled in the group and signed informed consent, followed the experimental treatment plan and visit plan, and could cooperate to observe adverse events and efficacy.

Who cannot join

  • Join another clinical study at the same time, unless it is during the follow-up period of an observational (non-interventional) or supportive care clinical study or interventional study.
  • Obstructive jaundice (bilirubin > 1.5 ULN) with inadequate biliary drainage.
  • Absolute neutrophil count (ANC) <1×109/L or platelet <80×109/L or hemoglobin < 8g/dL (based on the normal value of the clinical trial center)
  • Serum total bilirubin was 5 times higher than the upper limit of the normal reference range;
  • ALT, AST or ALP above 5 times the upper limit of the normal reference range;
  • Known active central nervous system metastatic and/or cancerous meningitis; Patients with previously treated BMS may participate provided they are stable (there is no evidence of imaging progression at least 4 weeks before the first dose of trial treatment, and any neurological symptoms have returned to baseline levels), there is no evidence of new or expanded BMS, and there is no evidence of new or expanded BMS. And no use of hormones greater than 10mg prednisone per day or equivalent for at least 14 days prior to trial treatment.
Show all 26Show fewer
  • Toxicity of previous anticancer treatment has not returned to grade 0 or 1 level (except hair loss);
  • Uncontrolled mass pleural effusion or massive ascites
  • Organ failure; Heart: Grade III and grade IV; Liver: reached Child-Pugh liver function grade B and C; Kidney: renal failure and uremia stage; Lungs: Symptoms of severe respiratory failure; Brain: A person with a disorder of consciousness.
  • History of heart disease:
  • 1) Patients with pre-existing arrhythmias with prolonged PR, QTc and/or QRS; 2) Acute myocardial infarction or congestive heart failure within 6 months; 3) Patients with long QT syndrome; 4) Patients who have been treated with antiarrhythmic drugs (e.g. quinidine IA, amiodarone III, sotalol); 11. Patients who have undergone major surgery within 4 weeks prior to the start of study treatment, or who expect to undergo major surgery (other than surgery for diagnostic purposes) during the study period; 12.HIV antibody positive, or have other acquired, congenital immunodeficiency diseases, or have a history of organ transplantation; 13. Uncontrolled co-morbidity, including but not limited to persistent or active infections, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmia, interstitial lung disease, severe chronic gastrointestinal disease with diarrhea, or mental illness/social conditions, will limit compliance with study requirements. Substantially increases the risk of developing AEs or impairs a patient's ability to give written informed consent.
  • 14. Patients with a history of Parkinson's disease or epilepsy, or who had a history of transient ischemic attacks, stroke, or traumatic brain injury with disturbance of consciousness in the 12 months prior to the study; 15. CTCAE2 grade infection that does not respond to treatment or CTCAE grade > 2 active clinically serious infection.
  • 16. Patients with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection who require treatment.
  • 17. Known or suspected prior allergy or hypersensitivity to any investigational drug or to any investigational drug excipient (duvaliumab, Sofantinib, Pabolizumab).
  • 18. Chronic diseases requiring immunological agents or hormone therapy; 19. Women who are pregnant (positive pregnancy test before medication) or breastfeeding; 20. Participated in a non-anti-PD1 /L1 antibody based clinical trial within the past 30 days.
  • 21. Patients with rare heritability should not participate in this clinical study.
  • Exit criteria
  • If any of the following events occur, the patient must withdraw from the study:
  • Patient voluntary withdrawal
  • Ineligibility discovered after enrollment
  • Poor compliance, failure to adhere to the protocol
  • Occurrence of adverse events (AE) or serious adverse events (SAE) where the investigator determines or the patient and family prefer not to continue treatment
  • Pregnancy
  • Inability to complete treatment according to the protocol after adjustment for grade 3/4 adverse events
  • Unforeseen, intolerable adverse reactions
  • Medical or ethical reasons impacting the continuation of the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Guanghai Dai contact

+861066947252

daigh301@vip.sina.com

China1 site, 1 recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

    Guanghai Dai, +861066947252, daigh301@vip.sina.com

    Recruiting

Other trials in China

About this study

This phase II trial studies how well gemcitabine, cisplatin and durvalumab/Pembrolizumab and surufatinib work in treating participants with advanced Biliary Tract Cancer. The international multicenter phase III clinical study TOPAZ-1 has confirmed that durvalumab combined with gemcitabine and cisplatin can bring survival benefits to advanced BTC. Whether if adding surufatinib to a standard of care can bring addition benefit needs to be explored.

Being tested
Surufatinib, Gemcitabine, Cisplatin, Durvalumab, Pembrolizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06708858
Study groupRoleWhat they receive
GC+IO+SurufatinibExperimentalSurufatinib Combined With Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab
Receives: Drug: Surufatinib; Drug: Gemcitabine; Drug: Cisplatin; Drug: Durvalumab; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR was defined as 2 CRs or 2 PRs with no evidence of progression in-between. Patients who discontinued randomized treatment without progression, received a subsequent anti-cancer therapy and then responded were not included as responders for ORR.

    Measured: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks and then every 8 weeks, through study completion, an average of 1 year

Secondary outcomes (4)

  1. PFS

    PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of treatment until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.

    Measured: Tumor assessments every 6 weeks for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death,through study completion, an average of 1 year.

  2. OS

    Overall Survival (OS) was defined as the time from the date of treatment until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique.

    Measured: through study completion, an average of 24 weeks

  3. conversion rate

    Number of patients amendable to curative surgical interventions defined as number of patients receiving curative surgical resection or transplantation after successful down-sizing of tumor(s) by intervention.

    Measured: through study completion, an average of 2 year

  4. safety

    Incidence, nature, and severity of adverse events graded according to the United States National Cancer Institute The Common Terminology Criteria for Adverse Events (NCI CTCAE 5.0)

    Measured: from the date of treatment to 90 days after last treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2024
  2. Study start15 Aug 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06708858
Sponsor's protocol ID
A2024-BTC-01
Status last verified
Nov 2024
First submitted
11 Nov 2024
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Surufatinib, Gemcitabine and Cisplatin in people with Advanced Biliary Tract Cancer, run by Dai, Guanghai 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 15 inclusion and 26 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 27 Nov 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?

Contact Guanghai Dai (+861066947252, daigh301@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks and then every 8 weeks, through study completion, an average of 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 NCT06708858.

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 27 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in