ClinicalTrials.gg
RecruitingNCT07676162Updated Sep 10, 2026

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 interventional study of SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab and Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab in Advanced Colorectal Cancer, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.

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Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 206 studies testing oxaliplatin in Colorectal Neoplasms — 21 open to participants now, 25 under way, 6 of them phase 3. Oxaliplatin · Colorectal Neoplasms.

Planned enrollment
28th of 183
300 · median 50
Started
2026
with 3 others
Phase 3
36 of 206
4 open now
Primary completion
2029-09
later than 22 of 24 live
Registered
207th of 206
by date

Among the 206 studies testing oxaliplatin in Colorectal Neoplasms, this one is the 28th largest by planned enrollment of the 183 interventional ones that give a count, is one of 4 that started in 2026, is one of 36 in phase 3, reaches primary completion later than 22 of the 24 other live ones, and was the 207th registered.

Colorectal Neoplasms

6,545 studies on the registry are indexed under Colorectal Neoplasms; 1,664 are open to participants now.

Browse Colorectal Neoplasms studies →

Open to participants now

21 of the 206 studies testing oxaliplatin in Colorectal Neoplasms are open now, in 12 countries. Recruiting first, the newest first:

16 more — sign in →

By country, each count listing its studies:

All 21 open studies →

About oxaliplatin

Oxaliplatin: first FDA approval 2002 (ELOXATIN). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 1,181 Colorectal Neoplasms studies recruiting now, 764 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 206 studies testing oxaliplatin in Colorectal Neoplasms, or all of them as a file.
02

Study 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 pharmacokinetic characteristics.

03

Conditions studied

  • Advanced Colorectal Cancer
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subjects voluntarily enroll in the study, sign , demonstrate good compliance and cooperate with follow-up visits.
  2. Aged between 18 and 75 years inclusive, male or female.
  3. (ECOG) performance status of 0 or 1.
  4. Estimated survival expectancy ≥ 12 weeks.
  5. or cytologically confirmed colorectal adenocarcinoma.
  6. No prior systemic anti-tumor therapy.
  7. Tumor tissue specimen must be provided, either archived within 1 year prior to first study treatment or newly collected fresh specimen.
  8. At least one per (RECIST) Version 1.1; the measurable lesion shall not have received prior local therapy such as radiotherapy.
  9. Adequate organ function with relevant laboratory tests completed within 7 days before the first study treatment.
  10. Male subjects with fertile female partners and fertile female subjects must use highly effective 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.

Exclusion criteria

Exclusion Criteria:

  1. Received systemic anti-tumor therapies (including 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.
  2. History of to monoclonal antibodies or any component of the investigational products to be administered in this study.
  3. Pre-existing peripheral neuropathy of Grade >1.
  4. 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.
  5. CT/MRI evidence of tumor encasement or invasion of major blood vessels.
  6. Non-gastrointestinal bleeding within 6 months prior to first study drug administration, or active peptic ulcer disease.
  7. Uncontrolled hypertension, or medical history of hypertensive crisis or hypertensive encephalopathy.
  8. History of severe cerebrovascular disease.
  9. Unresolved toxicities and/or complications from prior interventions that have not recovered to baseline.
  10. Subjects with a history of or current , or active .
  11. Known or suspected interstitial lung disease (ILD); moderate-to-severe pulmonary disease significantly impairing respiratory function or /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 treatment are excluded.
  12. Symptomatic moderate to severe ascites; uncontrolled moderate or greater pleural or pericardial effusion.
  13. Bowel obstruction within 3 months prior to first study treatment, or prior intestinal stent placement with the stent remaining in situ at screening.
  14. Uncontrolled or severe cardiovascular disease, or unstable angina/unstable arrhythmia occurring within 1 month before initiation of study treatment.
  15. Unexplained fever >38.5°C at screening or prior to first dose; severe infection ( 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.
  16. Previous or concurrent diagnosis of other malignant .
  17. Active or active infection.
  18. History of immunodeficiency including positive test, congenital/acquired immunodeficiency disorders, or prior solid organ transplantation.
  19. 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.
  20. Pregnant, breastfeeding females or females planning pregnancy during the study period.
  21. Uncontrolled psychiatric disorders, known alcohol abuse, illicit drug dependence, incarceration or other conditions that would preclude completion of study procedures.
  22. Any other conditions deemed inappropriate for study participation by the investigator, including abnormal laboratory values, familial/social factors or other risks leading to premature study discontinuation or confounding study results.
Terms in these criteria, in plain language(18)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Treatment group A

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

    Drug: SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab

  • Active comparator
    Treatment group B

    Standard First-line treatment

    Drug: Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab

Interventions

06

What researchers measure

Primary outcomes

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

    Time frame: From the first dose to the last visit, approximately11 months

Secondary outcomes

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

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

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

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

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

    Time frame: From the first dose to the last visit, approximately11 months

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

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

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

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

  6. Overall Survival (OS)

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

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

    Time frame: From the first dose to the last visit, approximately11 months

  8. Anti-SHR-A1811 Antibodies (ADA)

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

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

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Sep 2029, 37 months after the start.

Of 69 industry-sponsored phase 3 interventional studies under Colorectal Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 54. This study's planned 37 months is below that.

Counting every sponsor, half of 175 studies reached it within 50 months; a quarter within 35 and three quarters within 79.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2026
First posted
Jun 30, 2026
StartActual
Aug 28, 2026
Primary completionEst.
Sep 2029
CompletionEst.
Sep 2029
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07676162
Responsible party
Sponsor
First posted
Jun 30, 2026
Start date
Aug 28, 2026
Primary completion
Sep 2029 (estimated)
Completion
Sep 2029 (estimated)
Last update
Sep 10, 2026

Study contacts

Yingyi Jiang
Contact
yingyi.jiang.yj58@hengrui.com
0518-82342973
Zhengjin Zhang
Contact
zhengjin.zhang.zz79@hengrui.com
0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Trastuzumab rezetecan · Oxaliplatin · Levoleucovorin · Fluorouracil · Bevacizumab

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