Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether SHR-1701, an immune treatment designed to block PD-L1 and TGF-beta, can add to CAPOX chemotherapy and short-course radiotherapy before surgery for locally advanced rectal cancer. The planned sequence is one cycle of SHR-1701 plus CAPOX, radiotherapy, five further cycles, and then total mesorectal excision surgery.
The idea is that this combined treatment might destroy more tumour before surgery than chemoradiotherapy alone, increasing the chance of a pathological complete response (pCR), meaning no cancer is found in the removed tissue. The trial measures pCR, not whether people live longer or avoid surgery, and has no comparison group.
Worth knowing: This is a small, non-randomised phase 2 trial, so any change in pCR cannot be separated reliably from differences between the treated patients and those receiving usual care.
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 | NCT07478731 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 48 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Hong Qiu |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug SHR-1701 neoadjuvant
What it is measuring
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.
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
The goal of this clinical trial is to learn if SHR-1701 combine with chemoradiotherapy works to treat severe CRC.
Participants will take:
Induction: SHR-1701 combined with CAPOX for one cycle. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy/5F). Consolidation: SHR-1701 combined with CAPOX for five cycles, after which the subjects undergo TME surgery.
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
- 1: Sign the informed consent form and voluntarily participate in this study
2: Age 18-75
3: Pathologically confirmed rectal adenocarcinoma（At least meet any of the following criteria：cT3-4、cN2、EMVI+、MRF+）
4: pMMR or MSS/MSI-L rectal adenocarcinoma
5: The distance from tumor edge to the anal verge
6: Expect to complete R0 resection
7: Patients can swallow pills
8: ECOG PS 0-1
9: Patients has not received any anti-tumor treatment before, including surgery, radiotherapy, chemotherapy, targeting therapy and immunotherapy
10: Plan to complete surgery after neoadjuvant therapy
11: There is contraindication to surgery
12: Main organ function efficient, including blood routine examination, blood biochemical examination, coagulation function
13: Female subjects with reproductive capacity are required to undergo a serum pregnancy test 72 hours before starting the administration of the test drug, and the result must be negative. During the trial period and for at least 3 months after the last administration, they must take effective contraceptive measures (such as intrauterine devices, contraceptives, or condoms).
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 NCT07478731, registered by Hong Qiu 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.