Advanced Colorectal CancerPhase 3NCT06199973
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
A Phase 3 study testing SHR-A1811 and TAS-102, Regorafenib , Fruquintinib in people with Advanced Colorectal Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 in advanced colorectal cancer subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Colorectal Cancer
- What is being tested?
- SHR-A1811 and TAS-102, Regorafenib , Fruquintinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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) ;
- 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.
Who cannot join
- 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;
- 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;
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 in advanced colorectal cancer subjects.
- Conditions
- Advanced Colorectal Cancer
- Being tested
- SHR-A1811, TAS-102, Regorafenib , Fruquintinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
SHR-A1811(4.8 mg/kg) was administered intravenously on the first day of each cycle, once every 3 weeks (Q3W)
TAS-102, Regorafenib , FruquintinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 | Experimental | Not described Receives: Drug: SHR-A1811 |
| physician choiced treatment | Experimental | include: TAS-102, or Regorafenib, or Fruquintinib Receives: Drug: TAS-102, Regorafenib , Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive free survive assessed by Independent Review Committee
Measured: Every 6 weeks, up to 3 years
Secondary outcomes (5)
Security: adverse events
Measured: The first day of each cycle（21 days or 28 days）
Effectiveness: progressive free survive assessed by the researchers
Measured: Every 6 weeks, up to 3 years
Effectiveness: objective response rate assessed by the researchers
Measured: Every 6 weeks, up to 3 years
Effectiveness: duration of response assessed by the researchers
Measured: Every 6 weeks, up to 3 years
Effectiveness: overall survive assessed by the researchers
Measured: Every 6 weeks, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Mar 2024
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR-A1811 for Injection with TAS-102
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199973
- Sponsor's protocol ID
- SHR-A1811-309
- Status last verified
- Jul 2025
- First submitted
- 26 Dec 2023
- Last updated
- 17 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06199973
- Acronym / sponsor ID
- SHR-A1811-309
- Conditions
- Advanced Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 in advanced colorectal cancer subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- SHR-A1811 for Injection with TAS-102
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811 | Experimental | Drug: SHR-A1811 |
| physician choiced treatment | Experimental | Drug: TAS-102, Regorafenib , Fruquintinibinclude: TAS-102, or Regorafenib, or Fruquintinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
- 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;
- Subjects with a history of meningeal metastasis or current meningeal metastasis; active brain metastasis;
- uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-A1811SHR-A1811(4.8 mg/kg) was administered intravenously on the first day of each cycle, once every 3 weeks (Q3W) | Drug | SHR-A1811 |
| TAS-102, Regorafenib , Fruquintinibphysician 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. | Drug | physician choiced treatment |
Primary outcome
Progressive free survive assessed by Independent Review Committee
Time frame: Every 6 weeks, up to 3 years
5 secondary outcomes
Security: adverse events
Time frame: The first day of each cycle（21 days or 28 days）
Effectiveness: progressive free survive assessed by the researchers
Time frame: Every 6 weeks, up to 3 years
Effectiveness: objective response rate assessed by the researchers
Time frame: Every 6 weeks, up to 3 years
Effectiveness: duration of response assessed by the researchers
Time frame: Every 6 weeks, up to 3 years
Effectiveness: overall survive assessed by the researchers
Time frame: Every 6 weeks, up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-A1811 and TAS-102, Regorafenib , Fruquintinib in people with Advanced Colorectal Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progressive free survive assessed by Independent Review Committee (time frame: Every 6 weeks, up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.