Advanced Colorectal Cancer
Conditions
Brief summary
The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 in advanced colorectal cancer subjects.
Interventions
DRUGSHR-A1811
SHR-A1811(4.8 mg/kg) was administered intravenously on the first day of each cycle, once every 3 weeks (Q3W)
DRUGTAS-102, Regorafenib , Fruquintinib
physician choiced treatment,include: TAS-102(35 mg/m2, maximum 80 mg per dose), twice daily (BID) , once every 4 weeks (Q4W) , up to 3 years; or Regorafenib 160mg, once daily (QD) , once every 4 weeks (Q4W) , up to 3 years; or Fruquintinib 5mg once daily (QD) , once every 4 weeks (Q4W) , up to 3 years.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
SHR-A1811 for Injection with TAS-102
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Unresectable locally advanced or distant metastatic RAS/RAF wild-type colorectal cancer diagnosed histologically or cytologically; 2. After treatment with oxaliplatin, 5-fluorouracil (such as 5-FU, Capecitabine) , irinotecan (DMMR/MSI-H subjects also need anti-PD-1/PD-L1 antibody treatment failure) ; 3. According to the response evaluation criteria for solid tumors (RECIST 1.1) , having at least one measurable lesion, measurable lesions should not have received local treatment such as radiotherapy (lesions located within the previously treated area may also be targeted if progression is confirmed) . 4. ECOG physical strength score: 0-1; 5. Expected survival was ≥12 weeks; 6. 24-hour urine protein ≤1.0 g d) clotting: activated partial thromboplastin time (APTT) and international standard ratio (INR )≤1.5 × ULN (for use of a stable dose of anticoagulant therapy such as LMWH or Warfarin and INR can be screened within the expected range of anticoagulant therapy) ; 7. Eligible fertile patients (men and women) must agree to use a highly effective contraceptive method with their partner for at least 7 months during the trial and after the last dose; women of reproductive age must have a negative blood pregnancy test within 7 days before the first use of the study drug; 8. The subjects volunteered to join the study, signed the informed consent, good compliance, with follow-up.
Exclusion criteria
1. Subjects on systemic therapy with corticosteroid (\> 10 mg daily equivalent of prednisone) or other immunosuppressive agents, except for local inflammation and the prevention of allergy and nausea and vomiting, who had undergone major surgery or severe trauma within 4 weeks prior to the first corticosteroid of the study drug, or who required elective surgery during the trial, who had undergone minor traumatic surgery, such as needle biopsy, within 7 days prior to the first dose of the study drug; 2. Previous allergies to monoclonal antibody, formulation components of SHR-A1811 products, and fluorouracil medications; 3. Previous antineoplastic therapy toxicities did not revert to a CTCAE v5.0 grade rating of ≤1(except for toxicities that the investigator judged to have no safety risk, such as alopecia, etc.) or the level specified by the enrollment/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progressive free survive assessed by Independent Review Committee | Every 6 weeks, up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Security: adverse events | The first day of each cycle（21 days or 28 days） |
| Effectiveness: progressive free survive assessed by the researchers | Every 6 weeks, up to 3 years |
| Effectiveness: objective response rate assessed by the researchers | Every 6 weeks, up to 3 years |
| Effectiveness: duration of response assessed by the researchers | Every 6 weeks, up to 3 years |
| Effectiveness: overall survive assessed by the researchers | Every 6 weeks, up to 3 years |
Countries
China
Outcome results
None listed