Recruiting nowPhase 2Randomised
What this trial is trying to do
The researchers are testing whether adding fruquintinib, a drug that blocks signals used to grow tumour blood vessels, to short-course radiotherapy, tislelizumab (an immunotherapy), and CAPOX chemotherapy improves the tumour’s response before surgery. The comparison is with the same radiotherapy, immunotherapy, and chemotherapy without fruquintinib.
The idea is that the four-treatment combination could increase the chance that no cancer is found in the removed rectal specimen after treatment, measured as a pathological complete response (ypT0N0). The trial also measures side effects, so any possible improvement in response has to be weighed against the safety of adding fruquintinib.
Worth knowing: This is a small, phase 2 trial measuring complete response in the surgical specimen, not whether people live longer or avoid surgery.
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 | NCT07888309 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 50 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Ruijin Hospital |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Radiotherapy Short-Course Radiotherapy
- Drug Fruquintinib
- Drug Tislelizumab
- Drug CAPOX
What it is measuring
Proportion of participants achieving pathological complete response (pCR; ypT0N0)
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 randomized controlled clinical trial is to learn if adding fruquintinib to short-course radiotherapy, tislelizumab, and CAPOX can improve neoadjuvant treatment response and is safe for adults with locally advanced low rectal cancer. The main questions it aims to answer are:
* Does adding fruquintinib increase the pathological complete response (pCR) rate after neoadjuvant therapy?
* What adverse events do participants experience when fruquintinib is added to the regimen? Researchers will compare short-course radiotherapy followed by fruquintinib + tislelizumab + CAPOX with short-course radiotherapy followed by tislelizumab + CAPOX to see if adding fruquintinib improves the tumor response to neoadjuvant treatment.Participants will:
* Receive short-course radiotherapy (e.g., 25 Gy in 5 daily fractions over 1 week)
* Receive either fruquintinib + tislelizumab + CAPOX (experimental arm) or tislelizumab + CAPOX (control arm) for the neoadjuvant cycles
* Attend scheduled visits for tumor assessment (MRI, endoscopy, CT), blood tests, and adverse-event monitoring
* Undergo total mesorectal excision (TME) surgery after neoadjuvant treatment and have the specimen evaluated for pathological responseWritten 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. Has voluntarily signed a written informed consent form before any study-specific procedures.
2. Age 18 to 75 years (inclusive), with no restriction on sex.
3. Histologically confirmed locally advanced rectal adenocarcinoma by biopsy.
4. Pelvic MRI shows high-risk features, meeting any one of the following:
- Clinical tumor (cT) stage cT4a or cT4b (per AJCC 8th edition);
- Extramural venous invasion (EMVI);
- Clinical nodal (cN) stage cN2 (per AJCC 8th edition);
- Involvement of the mesorectal fascia (MRF);
- Enlarged lateral lymph nodes.
5. The inferior margin of the tumor is ≤ 10 cm from the anal verge.
6. Able to swallow tablets and capsules normally.
7. ECOG performance status 0-1.
8. No prior anti-tumor treatment for rectal cancer, including radiotherapy, chemotherapy, or surgery.
9. Planned to undergo surgical treatment after completion of neoadjuvant therapy.
10. No contraindications to surgery.
11. Adequate function of major organs, including:
1. Hematology (no blood or blood-product transfusion, and no use of G-CSF or other hematopoietic growth factors for correction within 14 days before the first treatment): absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelet count ≥ 75 × 10⁹/L; hemoglobin ≥ 90 g/L; white blood cell count ≥ 3.0 × 10⁹/L;
2.
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 NCT07888309, registered by Ruijin 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.