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Unresectable Biliary Tract CarcinomaPhase 2NCT06656559

Endoscopic Retrograde Cholangiopancreatography With Radiofrequency Ablation (ERCP-RFA) Combined With Envafolimab and Surufatinib Sequential Therapy for Unresectable Biliary Tract Carcinoma

A Phase 2 study testing Envafolimab and Surufatinib in people with Unresectable Biliary Tract Carcinoma, run by Tianjin Medical University Cancer Institute and 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 The sponsor has not verified this record for over two years, so it may be out of date.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 sequential treatment strategy of ERCP-RFA combined with envafolimab and surufatinib proposed in this study aims to maximally inhibit the progression of unresectable biliary tract tumors through the combined application of multiple therapeutic modalities. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Unresectable Biliary Tract Carcinoma
What is being tested?
Envafolimab and Surufatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Oct 2024to Aug 2026
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 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign written informed consent.;
  • 18-79 years of age (at the time of signing the informed consent);
  • Patients with confirmed diagnosis of biliary tract tumors by histopathologic examination;
  • Patients have received no previous local treatment or any systemic treatment, and have been considered unsuitable for radical therapies
  • Patients assessed by the investigator as unsuitable for or refusing chemotherapy
  • At least one measurable lesion (≥10 mm long diameter on CT scan for tumor lesions and ≥15 mm short diameter on CT scan for lymph node lesions according to RECIST 1.1 criteria);
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  • ECOG score: 0-1;
  • Expected survival ≥ 12 weeks;
  • Vital organ function in accordance with the following requirements (excluding any blood components and cell growth factors within 14 days): 1) blood routine: neutrophils ≥ 1.5 × 10^9/L platelet count ≥ 60 × 10^9/L hemoglobin ≥ 90 g/L; 2) liver and kidney function: serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula); total bilirubin (TBIL) ≤ 1.5 times ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 ULN (≤ 5ULN if liver function abnormalities are due to liver metastases); urine protein < 2 +; if urine protein ≥ 2 +,24-hour urine protein must show protein ≤ 1g;
  • Normal coagulation, no active bleeding and thrombosis disease 1) international normalized ratio INR ≤ 1.5 × ULN; 2) partial thromboplastin time APTT ≤ 1.5 × ULN; 3) prothrombin time PT ≤ 1.5 × ULN;
  • Non-surgically sterilized or female patients of childbearing age who need to use a medically recognized contraceptive (such as an intrauterine device, contraceptive pills or condom) during study treatment and within 3 months after the end of study treatment; non-surgically sterilized female patients of childbearing age must have a negative serum or urine HCG test within 7 days before study enrollment; and must be non-lactating; non-surgically sterilized or male patients of childbearing age who need to agree to use a medically recognized contraceptive during study treatment and within 3 months after the end of study treatment with their spouses.
  • Willing and able to be followed up until death or end of study or study termination.

Who cannot join

  • History of other malignancies (except basal cell carcinoma of the skin and/or carcinoma in situ of the cervix after radical surgery).
  • Previous treatment with other immune checkpoints; the subject known to have a prior allergy to macromolecular protein preparations;
  • Presence of any active autoimmune disease or history of autoimmune disease in the subject;
  • Subjects who are on immunosuppressive, or systemic, or absorbable topical hormone therapy for immunosuppression (dose >10mg/day prednisone or other equipotent hormone) and who continue to be on it within 2 weeks prior to enrollment.
  • Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage;
  • Patients with poorly controlled cardiac clinical symptoms or diseases such as: (1) NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
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  • Subjects with active infection or unexplained fever >38.5 degrees Celsius during screening and prior to the first dose (if the subject had fever due to the tumor, as determined by the investigator, he could be enrolled);
  • Previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.;
  • Subjects with congenital or acquired immune deficiency (e.g., HIV-infected individuals)
  • Subjects who have had a live bacterial vaccine or live attenuated vaccine vaccine within 4 weeks prior to the first dose of study treatment.
  • Subject has a known history of psychiatric drug abuse, alcoholism, or drug abuse;
  • Patients who cannot be administered orally
  • The subject had received treatment with traditional Chinese medicine within 2 weeks before the first treatment
  • ECOG score: ≥2
  • Patients with any other diseases, dysfunction caused by metastatic lesions, or suspected disease found by physical examination, indicating possible contraindications to the use of the investigational drug or putting the patients at high risk of treatment-related complications.

Trial locations and contacts

No sites are listed yet.

Yang Liu contact

+8617694950696

kgzllunli2021@163.com

About this study

Official title: Endoscopic Retrograde Cholangiopancreatography With Radiofrequency Ablation (ERCP-RFA) Combined With Envafolimab and Surufatinib Sequential Therapy for Unresectable Biliary Tract Carcinoma: A Prospective, Single-Arm, Single-Center Phase II Clinical Study

The sequential treatment strategy of ERCP-RFA combined with envafolimab and surufatinib proposed in this study aims to maximally inhibit the progression of unresectable biliary tract tumors through the combined application of multiple therapeutic modalities. ERCP-RFA, as a local treatment, first reduces the tumor burden and alleviates biliary obstruction through physical ablation. Subsequently, Envafolimab enables the body to more effectively identify and attack the remaining tumor cells by activating the immune system. Finally, Surufatinib as a targeted drug, further controls the growth and spread of tumors by inhibiting tumor angiogenesis and cell proliferation. The potential advantage of this combined treatment lies in the complementary effects of different therapeutic modalities.

Being tested
Envafolimab and Surufatinib

What participants receive

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

  • Envafolimab and SurufatinibDrug

    Envafolimab: 150mg, SC, qw Surufatinib: 150mg, p.o., qd

Study groups in NCT06656559
Study groupRoleWhat they receive
Envafolimab and SurufatinibExperimentalNot described
Receives: Drug: Envafolimab and Surufatinib

What is being measured

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

  1. Overall Survival

    Defined as the time from the start of study treatment to death due to any cause

    Measured: up to 12 months

Secondary outcomes (4)

  1. Disease Control Rate

    Complete response(CR)and partial response(PR)

    Measured: up to 12 months

  2. Progression-Free Survival

    Assessed by the investigator using RECIST v1.1, defined as the time from the start of study treatment to disease progression, or relapse after resection of liver metastases, or death due to any cause.

    Measured: up to 12 months

  3. Overall Response Rate

    Partial response (PR) plus complete response (CR)): assessed by the investigator using RECIST v1.1 criteria

    Measured: up to 12 months

  4. Adverse events was evaluated during received protocol therapy according to the NCI Common Terminology Criteria for NCI- CTCAE 5.0.

    safety

    Measured: up to 12 months

Timeline

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

  1. First posted24 Oct 2024
  2. Study startOct 2024 (estimated)
  3. Primary completionSep 2025 (estimated)
  4. Study completionAug 2026 (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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06656559
Sponsor's protocol ID
EC-2024-0131
Status last verified
Oct 2024
First submitted
23 Oct 2024
Last updated
24 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Envafolimab and Surufatinib in people with Unresectable Biliary Tract Carcinoma, run by Tianjin Medical University Cancer Institute and 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 12 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: status not confirmed, as of the sponsor's last update on 24 Oct 2024. 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?

Contact Yang Liu (+8617694950696, kgzllunli2021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: up to 12 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 NCT06656559.

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 24 Oct 2024.

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