Recruiting nowPhase 3
| Registry number | NCT07505472 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | open label |
| Taking part | 212 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | The First Hospital of Jilin University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Experimental Group
- Drug Control group
What it is measuring
pathologic complete response，pCR
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.
What this trial is trying to do
The researchers expect that adding surufatinib, an anti-angiogenic drug that blocks signals helping tumours form blood vessels, to short-course radiotherapy followed by CapeOX chemotherapy (capecitabine and oxaliplatin) plus the immune checkpoint inhibitor toripalimab could produce a stronger tumour response. The trial compares this combination with the same treatment without surufatinib in people with MRI-defined high-risk, locally advanced rectal cancer.
The idea is that combining blood-vessel blockade with chemotherapy and immune treatment may kill more tumour before surgery and reduce the risk of cancer returning nearby or spreading. The main measure is pathological complete response—the absence of detectable cancer in the surgical specimen—along with safety, rather than longer survival.
Worth knowing: The study is not randomised, and pathological complete response is an intermediate measure rather than proof that patients will live longer.
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.
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
Why is this study conducted? The purpose of this study is to improve the treatment efficacy, particularly the pathological complete response rate, in patients with high-risk/extremely high-risk locally advanced rectal cancer (LARC). In recent years, with the combination of neoadjuvant chemoradiotherapy and immunotherapy, some progress has been made in the treatment of rectal cancer, but there are still problems of regional recurrence and distant metastasis. Therefore, developing new treatment strategies for these patients is particularly important.
The treatment of rectal cancer usually involves surgery, radiation therapy, and chemotherapy. The current treatment methods have gradually shifted towards neoadjuvant chemoradiotherapy combined with immunotherapy, and have shown good potential in some clinical trials. These studies suggest that combining short-range radiotherapy, anti angiogenic drugs, and immune checkpoint inhibitors may play an important role in improving patient prognosis and enhancing tumor response rates.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
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. Patients and their families are able to understand and willing to participate in this clinical study and sign the informed consent form; 2. Age: 18~75 years old, male or female; 3. Pathologically confirmed rectal tubular adenocarcinoma; Differentiation into Grade 1-3, i.e., high, intermediate, and low-grade adenocarcinoma; pMMR/MSS phenotype; 4. Medium and low rectal cancer with the lower edge of the tumor located within 10cm from the anal verge; 5. Inclusion of treatment-naïve risk factors: cT4/cN2/mrMRF+/EMVI+ or lateral lymph node involvement.
6. No distant metastases; 7. ECOG score 0-1; 8. Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-). If HBsAg (+) or HBcAb (+), hepatitis B virus deoxyribonucleic acid (HBV-DNA) must < 1000 copies/mL or 200 IU/mL for enrollment; 9. HCV antibody (-); 10. Negative serum or urine pregnancy test for females of childbearing age; 11. Females of childbearing potential or males with potential reproductive partners should agree to use adequate contraception (such as intrauterine devices, birth control pills, or condoms) for the duration of the study and for 120 days after the end of the study; 12. No history of pelvic radiotherapy; 13. No history of surgery or chemotherapy for rectal cancer; 14. Not accompanied by systemic infections requiring antibiotic treatment; 15.
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 NCT07505472, registered by The First Hospital of Jilin University 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.