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AzTrials

Advanced Colorectal CancerPhase 3NCT07676162

A Clinical Study of SHR-A1811 in Combination With Chemotherapy and Bevacizumab Versus Standard Therapy as First-Line Treatment for Advanced Colorectal Cancer

A Phase 3 study testing SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab and Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab in people with Advanced Colorectal Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study adopts a randomized, open-label, positive-controlled, multicenter design, aiming to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and bevacizumab versus standard therapy as first-line treatment for advanced colorectal cancer, and to explore the drug's immunogenicity and… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Colorectal Cancer
What is being tested?
SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab and Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
28 Aug 2026to Sep 2029
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects voluntarily enroll in the study, sign informed consent, demonstrate good compliance and cooperate with follow-up visits.
  • Aged between 18 and 75 years inclusive, male or female.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Estimated survival expectancy ≥ 12 weeks.
  • Histologically or cytologically confirmed colorectal adenocarcinoma.
  • No prior systemic anti-tumor therapy.
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  • Tumor tissue specimen must be provided, either archived within 1 year prior to first study treatment or newly collected fresh specimen.
  • At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; the measurable lesion shall not have received prior local therapy such as radiotherapy.
  • Adequate organ function with relevant laboratory tests completed within 7 days before the first study treatment.
  • Male subjects with fertile female partners and fertile female subjects must use highly effective contraception throughout the study. Fertile female subjects must have a negative serum or urine human chorionic gonadotropin (HCG) test within 7 days prior to first study drug administration and shall not be breastfeeding.

Who cannot join

  • Received systemic anti-tumor therapies (including investigational agents) or major surgery within 4 weeks prior to the first study drug administration; palliative radiotherapy within 2 weeks or surgery within 4 weeks before study treatment initiation.
  • History of hypersensitivity to monoclonal antibodies or any component of the investigational products to be administered in this study.
  • Pre-existing peripheral neuropathy of Grade >1.
  • History of thromboembolic disease within 6 months or hemoptysis within 3 months before first study medication. Subjects with muscular venous thrombosis not requiring anticoagulation per investigator's assessment are eligible for enrollment.
  • CT/MRI evidence of tumor encasement or invasion of major blood vessels.
  • Non-gastrointestinal bleeding within 6 months prior to first study drug administration, or active peptic ulcer disease.
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  • Uncontrolled hypertension, or medical history of hypertensive crisis or hypertensive encephalopathy.
  • History of severe cerebrovascular disease.
  • Unresolved toxicities and/or complications from prior interventions that have not recovered to baseline.
  • Subjects with a history of or current leptomeningeal metastases, or active brain metastases.
  • Known or suspected interstitial lung disease (ILD); moderate-to-severe pulmonary disease significantly impairing respiratory function or autoimmune/connective tissue/inflammatory diseases involving the lung within 3 months before first dosing that may interfere with detection or management of drug-related pulmonary toxicity. Subjects who developed ≥Grade 3 ILD during prior immune checkpoint inhibitor treatment are excluded.
  • Symptomatic moderate to severe ascites; uncontrolled moderate or greater pleural or pericardial effusion.
  • Bowel obstruction within 3 months prior to first study treatment, or prior intestinal stent placement with the stent remaining in situ at screening.
  • Uncontrolled or severe cardiovascular disease, or unstable angina/unstable arrhythmia occurring within 1 month before initiation of study treatment.
  • Unexplained fever >38.5°C at screening or prior to first dose; severe infection (CTCAE Grade >2) within 4 weeks before study drug initiation; active pulmonary inflammation on baseline chest imaging, or clinical signs/symptoms of infection requiring oral or intravenous antibiotics within 2 weeks before first dosing.
  • Previous or concurrent diagnosis of other malignant malignancies.
  • Active hepatitis B or active hepatitis C infection.
  • History of immunodeficiency including positive HIV test, congenital/acquired immunodeficiency disorders, or prior solid organ transplantation.
  • Active pulmonary tuberculosis infection within 1 year prior to screening, or prior active pulmonary tuberculosis without standard anti-tuberculosis treatment even if diagnosed more than 1 year ago.
  • Pregnant, breastfeeding females or females planning pregnancy during the study period.
  • Uncontrolled psychiatric disorders, known alcohol abuse, illicit drug dependence, incarceration or other conditions that would preclude completion of study procedures.
  • Any other conditions deemed inappropriate for study participation by the investigator, including clinically significant abnormal laboratory values, familial/social factors or other risks leading to premature study discontinuation or confounding study results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yingyi Jiang contact

0518-82342973

yingyi.jiang.yj58@hengrui.com

Zhengjin Zhang contact

0518-82342973

zhengjin.zhang.zz79@hengrui.com

China1 site, 1 recruiting

  • Beijing cancer Hospital

    Beijing, Beijing Municipality, 100142

    Lin Shen

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study of SHR-A1811 in Combination With mFOLFOX6 (-1) and Bevacizumab Versus mFOLFOX6 in Combination With Bevacizumab as First-line Treatment for Advanced Colorectal Cancer.

This study adopts a randomized, open-label, positive-controlled, multicenter design, aiming to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and bevacizumab versus standard therapy as first-line treatment for advanced colorectal cancer, and to explore the drug's immunogenicity and pharmacokinetic characteristics.

Being tested
SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and BevacizumabDrug

    SHR-A1811 in combination with Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab

  • Oxaliplatin, Levo-leucovorin, Fluorouracil and BevacizumabDrug

    Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab

Study groups in NCT07676162
Study groupRoleWhat they receive
Treatment group AExperimentalSHR-A1811 in combination with Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab
Receives: Drug: SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab
Treatment group BActive comparatorStandard First-line treatment
Receives: Drug: Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) assessed by the Independent Review Committee (IRC)

    Measured: From the first dose to the last visit, approximately11 months

Secondary outcomes (9)

  1. Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)

    Measured: From the first dose to the last visit, approximately 11months

  2. Duration of Response (DoR) assessed by Independent Review Committee (IRC)

    Measured: From the first dose to the last visit, approximately 11months

  3. Progression-Free Survival (PFS) assessed by the Investigator

    Measured: From the first dose to the last visit, approximately11 months

  4. Objective Response Rate (ORR) assessed by the Investigator

    Measured: From the first dose to the last visit, approximately 11 months

  5. Duration of Response (DoR) assessed by the Investigator

    Measured: From the first dose to the last visit, approximately 11 months

  6. Overall Survival (OS)

    Measured: From the first dose to the last visit, approximately 11 months

  7. Incidence and severity of Adverse Events (AEs).

    Measured: From the first dose to the last visit, approximately11 months

  8. Anti-SHR-A1811 Antibodies (ADA)

    Measured: From the first dose to the last visit, approximately 11 months

  9. Plasma concentrations of toxin-conjugated antibody of SHR-A1811

    Measured: From the first dose to the last visit, approximately 11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2026
  2. Study start28 Aug 2026
  3. Primary completionSep 2029 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

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
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07676162
Sponsor's protocol ID
SHR-A1811-317
Status last verified
Sep 2026
First submitted
23 Jun 2026
Last updated
10 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab and Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab 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 10 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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?

Contact Yingyi Jiang (0518-82342973, yingyi.jiang.yj58@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) assessed by the Independent Review Committee (IRC) (time frame: From the first dose to the last visit, approximately11 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07676162.

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 10 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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