Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether giving CAPOX chemotherapy (oxaliplatin and capecitabine) together with tislelizumab, a PD-1 inhibitor that helps immune cells recognise cancer, before surgery can produce a complete response in locally advanced rectal cancer. The treatment is given for three cycles before the planned operation.
The idea is that shrinking or clearing the tumour before surgery might increase the chance of a clinical complete response (no detectable tumour on examinations) or a pathological complete response (no cancer found in the removed tissue). The trial is measuring these responses and safety, rather than comparing survival or bowel preservation with standard treatment.
Worth knowing: This is a small, non-randomised phase 2 trial, so it has no comparison group and cannot establish whether the combination is better than usual treatment.
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 | NCT06647680 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 35 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | The Affiliated Hospital of Qingdao University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles
What it is measuring
Clinical complete response and pathological complete response
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
To evaluate the safety and preliminary efficacy of preoperative chemotherapy and PD-1 inhibitor Tislelizumab for Rectal Cancer patients.Go through laboratory and medical tests to verify eligibility to enter the study, receive the experimental combination of drugs CAPOX (Oxaliplatin and Capecitabine) for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three years.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
- 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
- Be willing and able to provide written informed consent for the trial
- Age 18 years or greater
- Pathologically proven diagnosis of adenocarcinoma of the rectum
- Clinically determined to be stage T3 or T4, N0-N2, and M0
- Be fully active, able to carry on all pre-disease performance without restriction or Restricted in physically strenuous activity.
- Contrast-enhanced imaging of the abdomen and chest by CT to exclude distant metastases and provide local tumor stage
- Preoperative ECOG status score 0-1
- Preoperative ASA grade I-III
- Adequate bone marrow function
- Adequate renal and liver function
- No active second cancers
- Be willing and able to comply with all aspects of the protocol
- Women of childbearing potential must have used reliable contraception or have had a pregnancy test result within 7 days prior to enrollment.
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 NCT06647680, registered by The Affiliated Hospital of Qingdao 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.