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

NCT06199973 | Active Not Recruiting Phase 3

• 1 other identifier: SHR-A1811-309
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progressive free survive assessed by Independent Review Committee

  Every 6 weeks, up to 3 years

Secondary Outcomes (5)

• 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

Study Arms (2)

SHR-A1811

EXPERIMENTAL

Drug: SHR-A1811

physician choiced treatment

EXPERIMENTAL

include: TAS-102, or Regorafenib, or Fruquintinib

Drug: TAS-102, Regorafenib , Fruquintinib

Interventions

SHR-A1811 DRUG

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

SHR-A1811

TAS-102, Regorafenib , Fruquintinib 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.

physician choiced treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unresectable locally advanced or distant metastatic RAS/RAF wild-type colorectal cancer diagnosed histologically or cytologically;
• 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) ;
• 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) .
• ECOG physical strength score: 0-1;
• Expected survival was ≥12 weeks;
• 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) ;
• 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;
• The subjects volunteered to join the study, signed the informed consent, good compliance, with follow-up.

You may not qualify if:

• 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;
• Previous allergies to monoclonal antibody, formulation components of SHR-A1811 products, and fluorouracil medications;
• Subjects with a history of meningeal metastasis or current meningeal metastasis; active brain metastasis;
• uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
• 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);
• Other malignancies in the past 5 years, not including cured skin basal-cell carcinoma and carcinoma in situ of the cervix;
• Pregnant or lactating women.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 22198, China

Location

MeSH Terms

Interventions

trifluridine tipiracil drug combination; regorafenib; HMPL-013

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-A1811 for Injection with TAS-102

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 10, 2024
• Study Start: March 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

CN (1)