Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether focused, high-dose stereotactic body radiation therapy (SBRT), given between chemotherapy plus a PD-1 antibody, can damage the recurrent tumour and help the immune system attack it. The treatment sequence is intended for locally recurrent rectal cancer that cannot be removed with surgery, followed by possible surgery or maintenance treatment.
The idea is that combining these treatments could keep the cancer from growing for longer and might make surgery possible for some patients. The trial measures progression-free survival at one year and treatment safety, but it has no comparison group against standard treatment.
Worth knowing: This is a small, non-randomised Phase 2 study, so it cannot reliably show whether the combination is better than other treatments; one-year progression-free survival is not the same as living 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.
| Registry number | NCT06767007 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 31 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Sixth Affiliated Hospital, Sun Yat-sen University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Radiotherapy Stereotactic Body Radiation Therapy (SBRT)
- Drug PD1
- Drug Chemotherapy
What it is measuring
1 year PFS
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 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
This is a prospective study to delve into the therapeutic benefits of combining stereotactic body radiation therapy (SBRT) with PD-1 monoclonal antibody treatment for patients with unresectable locally recurrent rectal cancer (ULRRC). Our aim is to ascertain the safety of this approach and to offer robust, evidence-based medical guidance for the management of ULRRC using this innovative combination therapy.
Researchers will combine SBRT with PD-1 for ULRRC to see if this treatment can provide a benefit of survival.
Participants will:
1. Receive chemotherapy combined with PD-1 therapy for 1 cycle → SBRT treatment → Chemotherapy combined with PD-1 therapy for 3-6 cycles (assessment 6 weeks after SBRT treatment) → Surgery/Maintenance therapy.
2. Visit the clinic once every 3 months for checkups and testsWritten by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Rectal
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. Before implementing procedures related to the research protocol rather than routine care, informed consent forms with the subject's voluntary signature and dated must be obtained in accordance with regulations and institutional guidelines;
2. Patients with pMMR/MSS colorectal cancer;
3. Age between 18 and 75 years;
4. Tumor recurrence confirmed by histology, cytology, or imaging, and the multidisciplinary team (MDT) including surgeons assesses that the recurrent lesion cannot achieve a one-stage R0 resection (unresectable is defined as: 1. Pelvic MRI showing sacral infiltration at or above S2, 2. And/or lateral pelvic wall invasion, 3. And/or obturator vascular nerve infiltration, 4. After MDT discussion, there are no indications for a one-stage R0 resection, 5. The patient refuses total pelvic exenteration or debulking surgery);
5. Locally recurrent rectal adenocarcinoma without clear distant metastasis at diagnosis/MDT team assesses oligometastases as resectable/controllable (UICC 8th edition);
6. No prior radiotherapy, or a gap of more than 6 months between the completion of initial radiotherapy and the start of retreatment, with a previous radiotherapy dose of less than 50.4Gy, and no late toxicity in the small bowel or bladder;
7. ECOG performance status 0-1;
8.
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 NCT06767007, registered by Sixth Affiliated Hospital, Sun Yat-sen 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.