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
Overview
- Phase
- Phase 2
- Intervention
- Surufatinib/Toripalimab
- Conditions
- Refractory Metastatic Digestive System Carcinoma
- Sponsor
- Peking University
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Overall Survival (OS)
- Last Updated
- 4 years ago
Overview
Brief 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.
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.
Investigators
Shen Lin
professor
Peking University
Eligibility Criteria
Inclusion Criteria
- •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:
- •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;
- •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).
Exclusion Criteria
- •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;
- •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;
Arms & Interventions
Surufatinib 250mg/Toripalimab 240mg
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.
Intervention: Surufatinib/Toripalimab
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: From date of first dose of study drug until withdrawal of consent or death (up to approximately 1 year)
Duration from the date of initial treatment with Surufatinib plus toripalimab to the date of death due to any cause.
Secondary Outcomes
- adverse events(1 year)
- Progression-free Survival (PFS)(From date of first dose of study drug until disease progression, withdrawal of consent, death, new anti-cancer therapy (up to approximately 1 year))