Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether camrelizumab, an immunotherapy that helps immune cells recognise and attack cancer, can be combined with chemotherapy and long-course chemoradiotherapy before surgery as total neoadjuvant therapy for locally advanced low rectal cancer. The sequence is induction chemo-immunotherapy, chemoradiotherapy, then consolidation chemo-immunotherapy.
The idea is that producing more complete responses could allow some patients to avoid removal of the rectum and preserve the bowel, rather than proceeding directly to surgery. The trial measures complete response rate, not whether patients live longer or how long the cancer stays controlled.
Worth knowing: This is a small, single-arm phase II trial with no comparison group, so it cannot by itself show whether the regimen is better than standard 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 | NCT07527026 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 44 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Chinese PLA General Hospital |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Camrelizumab
What it is measuring
CR 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.
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
In pMMR/MSS locally advanced rectal cancer, can the innovative "chemo-immunotherapy induction + LCRT + chemo-immunotherapy consolidation" approach significantly improve the complete response rate and create opportunities for organ preservation?
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
- Aged 18-75 years, male or female;
Histologically confirmed T3-4 and/or N+ rectal adenocarcinoma (AJCC/UICC TNM staging, 8th edition);
Lower margin of the tumor ≤10 cm from the anal verge;
Expected to achieve R0 resection;
Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
Able to swallow tablets normally;
No prior anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc.;
Planned to undergo surgical treatment after neoadjuvant therapy;
No contraindications to surgery;
Laboratory tests must meet the following requirements: white blood cell count (WBC) ≥4×10⁹/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count ≥100×10⁹/L; hemoglobin ≥90 g/L; serum total bilirubin ≤1.5× upper limit of normal (ULN); serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN; serum creatinine ≤1.5× ULN or creatinine clearance ≥50 mL/min; international normalized ratio (INR) ≤1.5× ULN; activated partial thromboplastin time (APTT) ≤1.5× ULN;
Fertile male or female patients willing to use contraceptive measures during the trial.
Exclusion Criteria
- Prior or current receipt of any anti-tumor therapy for cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
Known genetic testing showing MSI-H (microsatellite inst…
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 NCT07527026, registered by Chinese PLA General Hospital 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.