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Trial Title:
Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan
NCT ID:
NCT06199973
Condition:
Advanced Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
SHR-A1811 for Injection with TAS-102
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1811
Description:
SHR-A1811(4.8 mg/kg) was administered intravenously on the first day of each cycle, once
every 3 weeks (Q3W)
Arm group label:
SHR-A1811
Intervention type:
Drug
Intervention name:
TAS-102, Regorafenib , Fruquintinib
Description:
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.
Arm group label:
physician choiced treatment
Summary:
The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 in
advanced colorectal cancer subjects.
Criteria for eligibility:
Criteria:
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/exclusion
criteria;
4. Subjects with a history of meningeal metastasis or current meningeal metastasis;
active brain metastasis;
5. uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated
drainage;
6. history of immunodeficiency, these included people who tested positive for HIV or
who had a fever of > 38.5 degrees of unknown cause before the first dose (cancer
fever, as judged by the researchers, could be enrolled); Severe infection (CTCAE >
Grade 2) occurred within 4 weeks before the first use of the study drug, such as
severe pneumonia, bacteremia, infection complications, etc. Baseline chest imaging
showed active pulmonary inflammation, active hepatitis B (HBV DNA ≥500 IU/mL) and
hepatitis C (HCV-RNA was higher than the lower limit of detection);
7. Other malignancies in the past 5 years, not including cured skin basal-cell
carcinoma and carcinoma in situ of the cervix;
8. Pregnant or lactating women.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Zip:
22198
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Li, Doctor
Phone:
021-38804518
Email:
siwei_bao@163.com
Start date:
March 1, 2024
Completion date:
June 2026
Lead sponsor:
Agency:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06199973
