Recruiting nowNot phased
What this trial is trying to do
The researchers are testing whether people with mismatch-repair-deficient/microsatellite-instability-high (dMMR/MSI-high) distal rectal cancer who have a complete response after PD-1 immunotherapy can be monitored with a “watch and wait” approach instead of immediate surgery.
The idea is that avoiding radical rectal surgery and additional treatment could preserve bowel and sexual function, avoid a permanent stoma, and reduce treatment-related harm and cost. The trial will measure how many people remain disease-free at one year, rather than directly comparing watch and wait with surgery in a randomised trial.
Worth knowing: This is a small, non-randomised study limited to patients who have already achieved a complete response after PD-1 treatment, so it cannot establish whether watch and wait is better than surgery for the broader group.
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 | NCT04643041 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | open label |
| Taking part | 47 people (planned) |
| Who can join | aged 18 Years to 80 Years |
| Run by | Sixth Affiliated Hospital, Sun Yat-sen University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Behavioural watch and wait
What it is measuring
1 year DFS rate
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.
Not phased. Not a drug-phase trial. Often a device, a procedure, or a change in how care is delivered.
How the researchers describe it
Immunotherapy has achieved significant therapeutic effect in DNA mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-H) colorectal cancer (CRC) , more than fifty percent of dMMR/MSI-H CRC patients might get pathological complete response(pCR) after PD-1 monoclonal antibody treatment. For distant rectal cancer(RC), radical resection and neoadjuvant chemotherapy or chemoradiotherapy might cause lots of treatment cost,damage to defecation and sexual function, acute toxicity, chronic dysfunction, even loss of anus and psychological disorder. This study aims to evaluate the effect and safety of watch and wait in patients with dMMR/MSI-H distal RC accessed pCR after PD-1 monoclonal antibody therapy.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- dMMR / MSI-H
- 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
Preliminary inclusion criteria：
- Histological identified rectal adenocarcinoma,
- Tumor biopsy immunohistochemical (IHC) identified dMMR, including one or more deficient of the MSH1,MSH2,MSH6 and PMS2 protein expression and diagnosed as deficient mismatch repair(dMMR), or next generation sequencing identified (MSI-H)； MRI identified tumor inferior margin lower than peritoneal reflection,
- Clinical staging TxNxM0, with or without positive MRF, with or without positive EMVI,
- Staging method：all patients undergo rectal palpation, high resolution MRI ± transrectal Ultrasound examination，positive perienteric lymph node(LN): short diameter ≥10mm LN or LN with typical metastatic shape and MRI character, clinical data should be re-evaluated and judged by center evaluation group when there are contradictory stagings，distant metastasis were excluded by chest and abdominal enhanced CT and pelvic enhanced MRI,
- No intestinal obstruction symptom，or obstruction relieved after proximal colostomy,
- No rectal surgery history,
- No chemotherapy or radiotherapy history,
- No biopharmaceutical treatment history(such as monoclonal antibody), immunotherapy(such as anti PD-1antibody, anti PD-L1 antibody, anti PD-L2 antibody or anti CTLA-4), or other research drug treatment,
- Endocrinotherapy history restriction:No
- Informed consent assigned, Final inclusion…
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 NCT04643041, 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.