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Refractory Metastatic Digestive System CarcinomaPhase 2NCT05030246

Trial of Surufatinib Combined With Toripalimab in the Treatment of Peritoneal Metastatic Carcinoma of Gastrointestinal or Primary Peritoneal Cancer

A Phase 2 study testing Surufatinib/Toripalimab in people with Refractory Metastatic Digestive System Carcinoma and Primary Peritoneal Cancer, run by Peking 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a phase II, single arm, open-label, single-center study to evaluate the efficacy and safety of Surufatinib combined with Toripalimab in patients with peritoneal metastatic carcinoma of gastrointestinal or primary peritoneal cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Surufatinib/Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteChina
Study dates
14 Jul 2021to 30 Jul 2023
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

  • Histologically or cytologically confirmed advanced peritoneal metastatic carcinoma of gastrointestinal or primary peritoneal cancer
  • Failed after standard treatment
  • Have evaluable lesions, including those that are not measurable
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  • Adequately understand the study and voluntarily sign the Informed Consent Form;
  • ≥18 years old;
  • Lab tests within 7 days before first dose:
  • 1) Absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥100×109/L, and hemoglobin ≥100g/L; 2) Serum total bilirubin ≤1.5 times the upper limit of normal (ULN); 3) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤2.5 times the ULN； 4) Patients without anticoagulant therapy: International Normalized Ratio (INR) ≤1.5 ULN and activated partial thromboplastin time (APTT) ≤1.5 ULN. If patients received anticoagulant therapy: INR ≤2 ULN and APTT was within the normal range 14 days before treatment; 5) Serum total bilirubin <1.5 times the upper limit of normal (ULN); 6) Urine protein < 2+; if ≥2+, 24-hour urine protein <1 g; 8. Male or females patients with reproductive potential must agree to use an effective contraceptive method, for example, double-barrier device, condom, oral or injected birth control medication or intrauterine device, during the study and within 90 days after study treatment discontinuation. All female patients are considered to be fertile, unless the patient had natural menopause or artificial menopause or sterilization (such as hysterectomy, bilateral oophorectomy or ovarian irradiation).

Who cannot join

  • Prior system treatment with antiPD1/PDL1/PDL2/CTLA-4 antibody or Sulfatinib;
  • Previous intraperitoneal treatment with immunologic agents;
  • Patients with digestive tract obstruction or uncontrolled active bleeding from the primary tumor;
  • Patients with any active autoimmune disease or a documented history of autoimmune disease: Patients with hypothyroidism but receiving a stable dose of thyroid hormone replacement therapy were included in the study, and subjects with stable type 1 diabetes were able to control their blood sugar;
  • Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severe impaired lung function, etc;
  • Prior major surgery within past 4 weeks and had not fully recovered from previous surgery;
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  • Active bleeding or abnormal coagulation, Prone to bleeding or receiving thrombolytic or anticoagulant therapy;
  • Hypertension that is not controlled by the drug, and is defined as: SBP≥140 mmHg and/or DBP≥90 mmHg;
  • Prior antitumor therapy (including chemotherapy, immunotherapy, biological treatment, Targeted therapy, etc) , or have not recovered from toxicities since the last treatment;
  • Pregnant or nursing;
  • previously received allogeneic stem cell or parenchymal organ transplantation;
  • Any significant clinical or laboratory abnormality that the investigator considers to influence the safety evaluators;
  • History of uncorrected serum electrolyte disturbances such as potassium, calcium, or magnesium;
  • Known human immunodeficiency virus (HIV) infection;
  • Active hepatitis B virus (HBV) and hepatitis C virus (HCV) infected persons;
  • A history of other malignancies within 5 years prior to inclusion, except for cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery;
  • Prior treatment with corticosteroids (dose > 10 mg/day prednisone or other hormones) or other immunosuppressive agents within 2 weeks, nasal or inhalation in allowed (dose > 10 mg/day prednisone or other hormones);
  • Severe, uncontrolled medical condition that would affect patients' compliance or obscure the interpretation of toxicity determination or adverse events, including active severe infection, uncontrolled diabetes, angiocardiopathy (heart failure > class II NYHA, LVEF <50%, myocardial infarction, unstable arrhythmia or unstable angina within past 6 months, cerebral infarction within past 3 months) or pulmonary disease ( interstitial pneumonia, obstructive pulmonary disease or symptomatic bronchospasm);
  • History with tuberculosis who are receiving or have received anti-TB treatment within 1 year;
  • Active infection;
  • Receiving another experimental drug or participating in a clinical study for another therapeutic purpose within the first 28 days prior to treatment initiation;
  • Any other disease, metabolic disorder, abnormal results of a physical examination or laboratory examination, and reasonably suspected disease or condition that may contraindication the use of the investigational drug, or affect the reliability of the study results, or place the patient at high risk for treatment complications, or affect patient compliance.

Trial locations and contacts

1 site in 1 country.

Lin Shen, MD contact

86-10-88196561

linshenpku@163.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Lin Shen, MD, 86-10-88196561

    Recruiting

Other trials in China

About this study

Official title: A Phase Ⅱ, Single-arm Study to Evaluate the Efficacy and Safety of Surufatinib Combined With Toripalimab in Peritoneal Metastatic Carcinoma of Gastrointestinal or Primary Peritoneal Cancer

This is a phase II, single arm, open-label, single-center study to evaluate the efficacy and safety of Surufatinib combined with Toripalimab in patients with peritoneal metastatic carcinoma of gastrointestinal or primary peritoneal cancer.

Read the detailed description

The study population is about 72 patients with advanced peritoneal metastatic carcinoma of gastrointestinal or primary peritoneal cancer, who fails or cannot tolerate standard therapies. Surufatinib 250 mg once a day (QD) will be orally administrated and Toripalimab 240mg will be intravenously administered every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. For Toripalimab, the upper time limit for treatment is 2 years. The primary objective is overall survival (OS) of Surufatinib combined with Toripalimab in patients with advanced solid advanced peritoneal metastatic carcinoma of gastrointestinal or primary peritoneal cancer.

Being tested
Surufatinib/Toripalimab

What participants receive

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

  • Surufatinib/ToripalimabDrug

    Also called HMPL-012/JS001

    Surufatinib 250mg will be taken orally once daily continuously through a 21-day cycle of study treatment. Toripalimab 240mg will be intravenously administered on Day 1 of each cycle.

Study groups in NCT05030246
Study groupRoleWhat they receive
Surufatinib 250mg/Toripalimab 240mgExperimentalSurufatinib 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.
Receives: Drug: Surufatinib/Toripalimab

What is being measured

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

  1. Overall Survival (OS)

    Duration from the date of initial treatment with Surufatinib plus toripalimab to the date of death due to any cause.

    Measured: From date of first dose of study drug until withdrawal of consent or death (up to approximately 1 year)

Secondary outcomes (2)

  1. Progression-free Survival (PFS)

    A duration from the date of initial treatment with Surufatinib combined with Toripalimab to disease progression or death of any cause.

    Measured: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anti-cancer therapy (up to approximately 1 year)

  2. adverse events

    Adverse events assessments are computed and categorized according to the Common Toxicity Criteria of the National Cancer Institute, version 5.0

    Measured: 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 posted1 Sep 2021
  2. Study start14 Jul 2021
  3. Primary completion30 Apr 2023 (estimated)
  4. Study completion30 Jul 2023 (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
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05030246
Sponsor's protocol ID
2021-012-CH04 IIT-GI
Status last verified
Jul 2021
First submitted
24 Aug 2021
Last updated
1 Sep 2021
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 Surufatinib/Toripalimab in people with Refractory Metastatic Digestive System Carcinoma and Primary Peritoneal Cancer, run by Peking 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 8 inclusion and 22 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 1 Sep 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.

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 Lin Shen, MD (86-10-88196561, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From date of first dose of study drug until withdrawal of consent or death (up to approximately 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 NCT05030246.

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 1 Sep 2021.

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