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

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-06-30

Brief Summary

The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 in advanced colorectal cancer subjects.

Conditions

Advanced Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-A1811

Group Type: EXPERIMENTAL

SHR-A1811

Intervention Type: DRUG

SHR-A1811(4.8 mg/kg) was administered intravenously on the first day of each cycle, once every 3 weeks (Q3W)

physician choiced treatment

include: TAS-102, or Regorafenib, or Fruquintinib

Group Type: EXPERIMENTAL

TAS-102, Regorafenib , Fruquintinib

Intervention Type: DRUG

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.

Interventions

SHR-A1811

SHR-A1811(4.8 mg/kg) was administered intravenously on the first day of each cycle, once every 3 weeks (Q3W)

Intervention Type: DRUG

TAS-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.

Intervention Type: DRUG

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;

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SHR-A1811-309

Identifier Type: -

Identifier Source: org_study_id