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Bile Duct CancerPhase 2CHOLNCT05911425

Combined Treatment of Treated Bile Duct Cancer

A Phase 2 study testing envolizumab , sovalteinib in people with Bile Duct Cancer, run by Zhejiang Cancer Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study will evaluate the efficacy and safety of envelizumab in combination with sovalteinib in the treatment of treated bile duct cancer, and explore treatment options to improve patient survival, while the study will attempt to explore the characteristics of the population benefiting from the treatment, and… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Bile Duct Cancer
What is being tested?
envolizumab , sovalteinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Jul 2023to 30 Jun 2025
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • the patient is 18-75 years old, can fully understand the content of this study, voluntarily join this study and cooperate with the study, and has full civil capacity
  • have a histologically or cytologically confirmed diagnosis of bile duct cancer
  • Patients with cholangiocarcinoma who have previously failed (disease progression or intolerability) to receive first-line or higher standard-containing therapy, including but not limited to chemotherapy, immunotherapy, targeted therapy, etc.; or who have relapsed within 6 months of postoperative adjuvant therapy;
  • patients receiving the first dose of this study at an interval of ≥ 28 days from the last treatment;
  • having a measurable lesion (≥10 mm long diameter on CT scan for non-lymph node lesions and ≥15 mm short diameter on CT scan for lymph node lesions according to RECIST 1.1 criteria)
  • an ECOG PS score: 0 to 1;
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  • subjects voluntarily enrolled in this study, with good compliance and cooperation with safety and survival follow-up.
  • have adequate organ function and have not had a blood transfusion, used granulocyte colony-stimulating factor (G-CSF), or used medication within 7 days prior to screening to correct: 1) Blood count: Absolute Neutrophil Count (ANC) 1.5 × 109/L, Platelet (PLT) ≥ 70 × 109/L, Hemoglobin (HGB) ≥ 90 g/L; 2) Liver function: serum total bilirubin (Total Bilirubin, TBIL) ≤ 1.5 × Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤3×ULN; serum albumin ≥28 g/L; Alkaline Phosphatase (ALP) ≤5×ULN; after conventional hepatoprotective treatment meeting the above criteria, and can be stable for at least 1 week after evaluation by the investigator can be enrolled; 3) Renal function: serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/mi (applying the standard Cockcroft-Gault formula); (4) Coagulation: International Normalized Ratio (INR) ≤ 1.5 /PT ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN; (5) nutritional status: body mass index BMI ≥ 18 kg/m2, weight ≥ 40 kg, serum albumin ≥ 3.0 g/dL;
  • life expectancy ≥ 6 months.

Who cannot join

  • subjects with prior or concurrent other malignancies, including combined or mixed hepatocellular/cholangiocarcinoma or potbelly cancer;
  • active brain metastases or spinal cord compression;
  • not having received systemic antitumor therapy prior to the first study drug treatment
  • prior antitumor therapy-related toxicity not recovered to CTCAE ≤ grade 1, except for alopecia and platinum-induced peripheral neuropathy ≤ grade 2
  • prior liver transplantation;
  • the subject has known prior hypersensitivity to macromolecular protein agents or drug components of sovalteinib
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  • subject has any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, previous thyroid surgery cannot be included; subject has vitiligo or asthma that has completely resolved in childhood and does not require any intervention in adulthood (subjects with vitiligo or asthma that has been in complete remission in childhood and does not require any intervention as an adult may be included; subjects with asthma requiring medical intervention with bronchodilators are not included);
  • subjects who are on immunosuppressive, immunomodulatory, or systemic, or absorbable topical hormone therapy for immunosuppressive purposes (doses >10 mg/day of prednisone or other equipotent hormone) and who continue to use them within 2 weeks prior to enrollment
  • clinically symptomatic ascites or pleural effusion that is not controlled by medication and requires therapeutic puncture or drainage prior to the first study drug therapy;
  • have had major surgical procedures or surgical incisions that have not fully healed prior to the first dose of the drug
  • patients with clinical cardiac symptoms or disease that are not well controlled, such as (1) NYHA class 2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
  • subjects with active infection or unexplained fever >38.5 degrees during screening and prior to the first dose (subjects with fever arising from tumors may be enrolled, as determined by the investigator)
  • patients with a history of prior and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severely impaired lung function
  • live vaccines administered less than 4 weeks prior to study drug administration or likely to be administered during the study period
  • subjects with a known history of psychotropic substance abuse, alcoholism, or drug use
  • women who are pregnant or breastfeeding;
  • are of childbearing potential but unwilling to accept effective contraception
  • subjects who, in the opinion of the investigator, should be excluded from this study, for example, subjects who, in the judgment of the investigator, have other factors that might force the study to be terminated mid-study, such as, other serious illnesses (including psychiatric illnesses) requiring comorbid treatment, serious laboratory test abnormalities, accompanying family or social factors that would compromise the safety of the subject, or data and sample collection.

About this study

Official title: Envolizumab in Combination With Sovalteinib for the Treatment of Treated Bile Duct Cancer in an Open, Single-arm, Phase II Clinical Study

The study will evaluate the efficacy and safety of envelizumab in combination with sovalteinib in the treatment of treated bile duct cancer, and explore treatment options to improve patient survival, while the study will attempt to explore the characteristics of the population benefiting from the treatment, and construct a preliminary efficacy prediction model by detecting markers in blood to provide a theoretical basis for implementing precise treatment.

Being tested
envolizumab , sovalteinib
Medical subject headings
Bile Duct Neoplasms

What participants receive

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

  • envolizumab , sovalteinibDrug

    Envolizumab 300mg, Q2W, day 1, subcutaneous injection Soventinib 200mg, Q2W, once daily, orally Every 2 weeks as a cycle.

Study groups in NCT05911425
Study groupRoleWhat they receive
Prospective ResearchOtherEnvolizumab 300mg, Q2W, day 1, subcutaneous injection Soventinib 200mg, Q2W, once daily, orally Every 2 weeks as a cycle.
Receives: Drug: envolizumab , sovalteinib

What is being measured

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

  1. ORR

    Proportion of patients whose tumors shrink by a certain amount and remain for a certain period of time

    Measured: through disease progression, an average of 6 months

Secondary outcomes (4)

  1. DoR

    The time from the first evaluation of the tumor as CR or PR to the first evaluation of PD (Progressive Disease) or death from any cause

    Measured: through disease progression, an average of 6 months

  2. DCR

    Time from the start of the first evaluation of the tumor as CR, PR or SD to the first evaluation of PD (Progressive Disease) or death from any cause

    Measured: through disease progression, an average of 6 months

  3. PFS

    Time from treatment initiation to first tumor progression or death

    Measured: through disease progression, an average of 1 6 months

  4. OS

    Time from the start of treatment to death from any cause

    Measured: through patient death, an average of 1 year

Timeline

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

  1. First posted22 Jun 2023
  2. Study start1 Jul 2023 (estimated)
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Jun 2025 (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
Model description
envolizumab sovalteinib
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05911425
Sponsor's protocol ID
IRB-2023-222
Acronym
CHOL
Status last verified
Jun 2023
First submitted
8 Jun 2023
Last updated
22 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing envolizumab , sovalteinib in people with Bile Duct Cancer, run by Zhejiang Cancer Hospital.

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 9 inclusion and 18 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

ORR (time frame: through disease progression, an average of 6 months). 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 NCT05911425.

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 22 Jun 2023.

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