Recruiting nowPhase 3Randomised
What this trial is trying to do
The trial asks whether adding SHR-A1811 to oxaliplatin, levo-leucovorin, fluorouracil and bevacizumab can control advanced colorectal cancer better than the same chemotherapy and bevacizumab without SHR-A1811. It will also examine safety, how the body handles the drug and whether the immune system reacts to it.
The comparison is against standard first-line treatment, and the main test is whether patients go longer before the cancer grows, measured as progression-free survival by an independent review committee. The researchers will also compare safety, but this outcome does not directly measure whether patients live longer.
Worth knowing: The study is open-label, so patients and clinicians know which treatment is being given, and its main outcome is delaying progression rather than overall survival.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07676162 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 300 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab
- Drug Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab
What it is measuring
Progression-Free Survival (PFS) assessed by the Independent Review Committee (IRC)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 3. Compares the treatment against current standard care in a large group. This is the design that changes practice.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Not yet treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
1. Subjects voluntarily enroll in the study, sign informed consent, demonstrate good compliance and cooperate with follow-up visits.
2. Aged between 18 and 75 years inclusive, male or female.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Estimated survival expectancy ≥ 12 weeks.
5. Histologically 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 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.
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 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.
Exclusion Criteria
1.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07676162, registered by Suzhou Suncadia Biopharmaceuticals Co., Ltd. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.