Ampullary CarcinomaPhase 2NCT06062485
Surufatinib Combined With Toripalimab and AG Regiments for First-line Treatment of Unresectable or Relapsing Metastatic Ampullary Carcinoma
A Phase 2 study testing Surufatinib+Toripalimab+AG in people with Ampullary Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
A Phase Ⅱ, single-arm study to assess the safety, tolerability, and efficacy of Surufatinib Combination With Toripalimab in Patients With recurrent or metastatic ampulla tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ampullary Carcinoma
- What is being tested?
- Surufatinib+Toripalimab+AG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old;
- Unresectable or relapses metastatic ampullary malignancies identified by histopathology or cytology,with histological subtypes of parenteral type;
- Have not received systematic treatment for unresectable or metastatic ampulla malignant tumor;A scheme of adjuvant or neoadjuvant chemotherapy and 6 months after the chemotherapy recurrence can into the group;
- ECOG score 0 or 1;
- Expected survival≥12 weeks;
- Have at least one measurable lesion;
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- Major organ functions within 7 days prior to treatment shall meet the following criteria:
- (1)Hemoglobin(HB)≥90 g/L; (2)neutrophil absolute value(ANC)≥1.5×109/L; (3)Platelet(PLT)≥100×109/L;
- 8.Biochemical examination shall meet the following standards:
- Total bilirubin(TBIL)≤3 times the upper limit of normal value(ULN);
- ALT and aspartate aminotransferase AST≤2.5×ULN,and ALT and AST≤5×ULN with liver metastasis;
- Serum creatinine(Cr)≤1.5×ULN or creatinine clearance(CCr)≥60ml/min;
- 9.Doppler ultrasound evaluation:left ventricular ejection fraction(LVEF)≥the lower limit of normal value(50%)；
- 10.Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures;
- 11.Subjects voluntarily joined the study and signed an informed consent form(ICF);
- 12.It is expected that the patient has good compliance and can follow up the efficacy and adverse reactions according to the protocol requirements.
Who cannot join
- Patients who have previously been treated with small-molecule drugs similar to VEGFR-TKI,such as Anlotinib,Sunitinib,Sorafenib,Lenvatinib,Apatinib,etc.
- Anti-pd-1 or anti-PD-L1/L2 antibodies or anti-cytotoxic T lymphocyte-associated antigen(CTLA-4)antibodies were used in the past;
- Malignant ampulla obstruction after clinical intervention was not resolved or anti-infective therapy was required 14 days before the first study of drug therapy;
- Patients with severe allergic history or allergic constitution;
- Pregnant or lactating women;
- Patients who have participated in other clinical trials and have not terminated the trials;
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- Patients with any severe and/or uncontrolled medical condition,including:
- (1)Patients with unsatisfactory blood pressure control(systolic blood pressure≥150 mmHg,diastolic blood pressure≥100 mmHg); (2)Patients with grade I or above myocardial ischemia or myocardial infarction,arrhythmias(including QTc≥480ms),and≥grade 2 congestive heart failure(New York Heart Association(NYHA)grades); (3)Active or uncontrolled severe infection(≥CTC AE grade 2 infection); (4)Cirrhosis,decompensated liver disease,active hepatitis or chronic hepatitis require antiviral therapy; (5)Renal failure requiring hemodialysis or peritoneal dialysis; (6)A history of immunodeficiency,including HIV positive or other acquired or congenital immunodeficiency diseases,or a history of organ transplantation; (7)Urine protein≥++was indicated by two consecutive urine routine,and the 24-hour urine protein quantity was confirmed to be>1.0 g; (8)Mental illness,including epilepsy,dementia,severe depression,mania,etc.
- 8.Received major surgical treatment,open biopsy,or significant traumatic injury within 28 days prior to grouping(specifically in conjunction with clinical evaluation);
- 9.History of any active autoimmune disease or autoimmune disease,including but not limited to interstitial pneumonia,uveitis,inflammatory bowel disease,hepatitis,pituitary inflammation,vasculitis,systemic lupus erythematosus,etc.;
- 10.The patient currently has active gastric and duodenal ulcers,ulcerative colitis and other digestive diseases,or active bleeding from unexcised tumors,or other conditions determined by researchers that may cause gastrointestinal bleeding and perforation;
- 11.Patients with any physical signs or history of bleeding,regardless of severity;Unhealed wounds,ulcers,or fractures were observed in patients with any bleeding or bleeding events≥CTCAE grade 3 during the first 4 weeks of enrollment;
- 12.Experienced arteriovenous thrombotic events,such as cerebrovascular accidents(including temporary ischemic attacks),deep vein thrombosis and pulmonary embolism,within 6 months;
- 13.Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders;
- 14.Subjects with dysphagia or known drug absorption disorders.
- 15.The researchers considered other conditions unsuitable for inclusion.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Surufatinib Combined With Toripalimab and AG Regiments for First-line Treatment of Unresectable or Relapsing Metastatic Ampullary Carcinoma
A Phase Ⅱ, single-arm study to assess the safety, tolerability, and efficacy of Surufatinib Combination With Toripalimab in Patients With recurrent or metastatic ampulla tumors.
- Conditions
- Ampullary Carcinoma
- Being tested
- Surufatinib+Toripalimab+AG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surufatinib+Toripalimab+AGDrug
This is a single-arm, prospective, exploratory clinical study of unresectable or relapsing metastatic ampullary tumors who were not systematically treated with surufatinib in combination with PD-1 antibody and AG regimen.Until the investigator assesses loss of clinical benefit, unacceptable toxicity, decision by the investigator or subject to withdraw treatment, or death, whichever comes first.The AG regimen does not exceed 8 cycles, and maintenance therapy with surufatinib combined with toripalimab can be continued if the patient has not progressed after 8 cycles. The treatment period was 21 days; Tumor treatment and survival status were recorded until disease progression (RECIST 1.1) or death (during patient treatment).
Surufatinib (200mg，qd，Q3W）；Toripalimab(240mg IV d1, Q3W)；AG（Albumin-bound paclitaxel: 125mg/m2，IV，d1，d8，Q3W）Gemcitabine: 1000 mg/m2, IV，d1，d8，Q3W）
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Drug: Surufatinib+Toripalimab+AG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Measured: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Secondary outcomes (4)
Progression free survival (PFS)
Tumor assessment will be performed using radiography method every 6 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1
Measured: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Overall survival (OS）
Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Measured: from randomization until death due to any cause, assessed up to 3 year
Disease control rate (DCR）
Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Measured: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Safety and tolerance evaluated by incidence, severity and outcomes of AEs
Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 5.0
Measured: from first dose to 30 days post the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ampullary CarcinomaStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062485
- Sponsor's protocol ID
- HMPL-012-E2-BTC-101
- Status last verified
- Apr 2023
- First submitted
- 25 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Surufatinib Combined With Toripalimab and AG Regiments for First-line Treatment of Unresectable or Relapsing Metastatic Ampullary Carcinoma
- ClinicalTrials.gov ID
- NCT06062485
- Acronym / sponsor ID
- HMPL-012-E2-BTC-101
- Conditions
- Ampullary Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 2 Oct 2023 (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 Phase Ⅱ, single-arm study to assess the safety, tolerability, and efficacy of Surufatinib Combination With Toripalimab in Patients With recurrent or metastatic ampulla tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Surufatinib+Toripalimab+AG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Over 18 years old;
- Unresectable or relapses metastatic ampullary malignancies identified by histopathology or cytology,with histological subtypes of parenteral type;
- Have not received systematic treatment for unresectable or metastatic ampulla malignant tumor;A scheme of adjuvant or neoadjuvant chemotherapy and 6 months after the chemotherapy recurrence can into the group;
- ECOG score 0 or 1;
- Expected survival≥12 weeks;
Key exclusion criteria (16 listed)
- Patients who have previously been treated with small-molecule drugs similar to VEGFR-TKI,such as Anlotinib,Sunitinib,Sorafenib,Lenvatinib,Apatinib,etc.
- Anti-pd-1 or anti-PD-L1/L2 antibodies or anti-cytotoxic T lymphocyte-associated antigen(CTLA-4)antibodies were used in the past;
- Malignant ampulla obstruction after clinical intervention was not resolved or anti-infective therapy was required 14 days before the first study of drug therapy;
- Patients with severe allergic history or allergic constitution;
- Pregnant or lactating women;
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 |
|---|---|---|
| Surufatinib+Toripalimab+AGThis is a single-arm, prospective, exploratory clinical study of unresectable or relapsing metastatic ampullary tumors who were not systematically treated with surufatinib in combination with PD-1 antibody and AG regimen.Until the investigator assesses loss of clinical benefit, unacceptable toxicity, decision by the investigator or subject to withdraw treatment, or death, whichever comes first.The AG regimen does not exceed 8 cycles, and maintenance therapy with surufatinib combined with toripalimab can be continued if the patient has not progressed after 8 cycles. The treatment period was 21 days; Tumor treatment and survival status were recorded until disease progression (RECIST 1.1) or death (during patient treatment). Surufatinib (200mg，qd，Q3W）；Toripalimab(240mg IV d1, Q3W)；AG（Albumin-bound paclitaxel: 125mg/m2，IV，d1，d8，Q3W）Gemcitabine: 1000 mg/m2, IV，d1，d8，Q3W） | Drug | Experimental |
Primary outcome
Objective response rate (ORR)
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
4 secondary outcomes
Progression free survival (PFS)
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Overall survival (OS）
Time frame: from randomization until death due to any cause, assessed up to 3 year
Disease control rate (DCR）
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Safety and tolerance evaluated by incidence, severity and outcomes of AEs
Time frame: from first dose to 30 days post the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surufatinib+Toripalimab+AG in people with Ampullary Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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 16 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 2 Oct 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?
Contact Du Juan, M.D. Ph.D (86-025-83106666, dujunglyy@163.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: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year). 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 2 Oct 2023.