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Biliary Tract CancerNCT05056116

A Safety and Efficacy Study of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer

A study testing Surufatinib Toripalimab in people with Biliary Tract Cancer, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

A Phase Ⅱ, open-label, single-arm study to assess the safety, tolerability, and efficacy of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Biliary Tract Cancer
What is being tested?
Surufatinib Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Sep 2021to Jun 2024
Phase
Interventional
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

  • Male and Female aged between 18 and 75 years are eligible; Provision of written Informed Consent Form (ICF) prior to any study specific procedures;
  • Advanced (unresectable) or metastatic biliary carcinomas that have been histologically or cytologically confirmed include intrahepatic or extrahepatic carcinoma of the bile duct, carcinoma of the gallbladder, and carcinoma of the ampullary of fatt, and have been histologically confirmed as adenocarcinoma;
  • Patients who have previously received disease progression or toxic side effects after first-line systemic chemotherapy are not tolerated;The standard first-line chemotherapy regimen was defined as a two-drug combination regimen of gemcitabine plus cisplatin, gemcitabine plus gio, or capecitabine plus oxaliplatin.Failure of first-line standard chemotherapy was defined as progression of disease during treatment or within 6 months after the last treatment;Or the toxic side effects of the treatment process are intolerable;
  • Presence of at least one measurable target lesion for further evaluation according to RECIST criteria;
  • Patients who had previously received A VEGF or VEGFR-targeted drug required progression 4 months after the last dose;
  • No systemic antitumor therapy in 4 weeks;
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  • The patient has no evidence of biliary obstruction unless the obstruction is controlled by local treatment or the patient is decompressed by endoscopic or percutaneous stenting, and bilirubin is subsequently reduced to below the upper limit of 1.5x normal (ULN);
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1;Predicted survival ≥3 months;
  • Screening laboratory values must meet the following criteria (within past 14 days):
  • neutrophils ≥1.5×109/L ;
  • platelets ≥9g/dL；
  • hemoglobin ≥ 9.0 g/dL;
  • albumin≥3g/dL；
  • total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1.5╳ULN;
  • Voluntary enrollment, good compliance, can cooperate with the experiment observation, and signed a written informed consent;
  • Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 6 months after the last dose of study drug.

Who cannot join

  • Prior treatment with Surufatinib,or other antiangiogenic drugs were used within 6 months;
  • Prior antitumor therapy with chemotherapy, radical radiation therapy ，biological immunotherapy，targeted therapy within 4 weeks.
  • Prior participation in other clinical trials not approved or listed in China within past 4 weeks；
  • Prior major surgery within past 4 weeks (diagnostic surgery excluded);
  • International standardized ratio (INR) >1.5 or partially activated prothrombin time (APTT) >1.5×ULN;
  • Clinically significant severe electrolyte abnormality judged by investigator ;
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  • Hypertension that is not controlled by the drug, and is defined as: SBP≥140 mmHg and/or DBP≥90 mmHg;
  • Currently suffering from poorly controlled diabetes (after regular treatment, fasting plasma glucose concentration ≥10mmol/L);
  • The patient currently has disease or condition that affects the absorption of the drug, or the patient cannot be administered orally;
  • Digestive tract disease such as gastric and duodenal active ulcer, ulcerative colitis or unresected tumor, or other conditions determined by the investigator that may cause gastrointestinal bleeding and perforation;
  • Evidence of bleeding tendency or history within 3 months, or thromboembolic event (including a stroke event and/or a transient ischemic attack) occurred within 12 month;
  • Cardiovascular disease of significant clinical significance (myocardial infarction, unstable arrhythmia or unstable angina ，Coronary Artery Bypass Grafting within past 6 months,)；
  • Had other malignant tumors in the past 5 years (except for basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ that have been effectively controlled);
  • Active or uncontrolled severe infection (≥CTCAE2 infection);
  • Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (>2000IU/ml);
  • Evidence with active CNS disease or previous brain metastases;
  • The toxicity associated with previous anti-tumor treatment has not recovered to ≤CTCAE1, except for peripheral neurotoxicity and alopecia ≤CTCAE2 caused by oxaliplatin;
  • Pregnant or nursing;
  • Transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony stimulating factor (G-CSF), had been received within 14 days before enrollment;
  • Tumor involving skin and/or pharyngeal mucosa with ulceration;
  • Patients with a history of psychotropic drug abuse and unable to quit or with mental disorders;
  • Any other disease, with clinical significance of metabolic abnormalities, abnormal physical examination or laboratory abnormalities, according to researchers, there is reason to doubt is not suitable for the use of study drugs in patients with a disease or condition (such as have a seizure and require treatment), or will affect the interpretation of results, or make the patients at high risk.
  • Routine urine indicated that urine protein ≥2+, and the 24-hour urine protein volume >1.0g;
  • Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events.
  • Prior receipt of any anti-PD-1 /PD-L1/PD-L2 antibody or anti-cytotoxic T lymphocyte associated antigen-4 (CTLA-4) antibody or any other antibody acting on T cell co-stimulation or checkpoint pathway (e.g. OX40, CD137, etc.)

Trial locations and contacts

1 site in 1 country.

Renhao Wang, MD contact

13605207887

wangrenhao@126.com

Bin Zhang, MD contact

15252039221

zhangbin@xzhmu.edu.cn

China1 site, 1 recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    Renhao Wang, MD, 13605207887, wangrenhao@126.com

    Bin Zhang, MD

    Recruiting

Other trials in China

About this study

Official title: A Safety and Efficacy Study of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer : a Phase Ⅱ Study

A Phase Ⅱ, open-label, single-arm study to assess the safety, tolerability, and efficacy of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer.

Read the detailed description

A Phase 2, open-label, single-arm study to assess the safety, tolerability, and efficacy of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer).

Being tested
Surufatinib Toripalimab
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.

  • Surufatinib ToripalimabDrug

    Also called Surufatinib/JS001

    Surufatinib at a dose of 250mg Qd, with humanized anti-PD-1 monoclonal antibody Toripalimab injected intravenously 240mg per 3 weeks until disease progresses or unacceptable tolerability occurs.

Study groups in NCT05056116
Study groupRoleWhat they receive
Biliary Tract CancerExperimentalSurufatinib 250mg/Toripalimab 240mg
Receives: Drug: Surufatinib Toripalimab

What is being measured

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

  1. Objective response rate(ORR)

    The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%). In the event of PR or CR, the subjects should confirm it no less than 4 weeks after the first evaluation. CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1(each cycle is 21 days))

    Measured: up to 24 months

Secondary outcomes (2)

  1. Progression-free survival (PFS)

    To assess the efficacy of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer, patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

    Measured: up to 12 months

  2. Overall survival (OS)

    The time interval between the start date of study drug and the date of death (any cause).

    Measured: up to 36 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 Sep 2021
  2. Study start1 Sep 2021
  3. Primary completionJun 2022 (estimated)
  4. Study completionJun 2024 (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 N/A
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
NCT05056116
Sponsor's protocol ID
HMPL-012-SPRING-B101
Status last verified
Dec 2021
First submitted
15 Sep 2021
Last updated
27 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Surufatinib Toripalimab in people with Biliary Tract Cancer, run by The Affiliated Hospital of Xuzhou Medical University 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 16 inclusion and 25 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 27 Dec 2021. 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.

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 Renhao Wang, MD (13605207887, wangrenhao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate(ORR) (time frame: up to 24 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 NCT05056116.

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 Dec 2021.

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