Recruiting nowPhase 2Randomised
| Registry number | NCT07544784 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 73 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Fudan University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug AK104 with radiotherapy
- Drug Standard of therapy
What it is measuring
ORR
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.
What this trial is trying to do
The trial asks whether adding AK104, an antibody that blocks two immune checkpoints (PD-1 and CTLA-4), plus radiotherapy to standard first-line treatment can produce more tumour shrinkage in colorectal cancer that has spread to the liver than standard treatment alone.
The researchers expect that combining immune activation from AK104 and local tumour damage from radiotherapy could improve the objective response rate (ORR), the proportion of patients whose tumours shrink by a defined amount. The comparison is against standard therapy, and the measured improvement is tumour response rather than longer survival.
Worth knowing: This is a small, single-centre phase 2 trial, and ORR is an intermediate measure rather than proof that patients live longer.
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.
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
This is a prospective, randomized controlled, single-center phase II clinical study. It aims to compare the efficacy of AK104 plus radiotherapy combined with standard therapy versus standard therapy as first-line treatment for liver metastases from metastatic colorectal cancer.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Not yet treated
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. Age ≥ 18 years, with no gender restriction;
2. Histologically or cytologically confirmed colorectal cancer;
3. Presence of liver metastases, with at least one measurable target lesion (per RECIST 1.1 criteria) in addition to a single liver metastatic lesion amenable to radiotherapy; patients with initially resectable colorectal cancer liver metastases are excluded;
4. Treatment-naive patients; or patients with postoperative recurrence who have not received any anti-tumor therapy within 6 months and at least 6 months have elapsed since the last adjuvant chemotherapy;
5. ECOG performance status score of 0-1;
6. Expected overall survival ≥ 3 months;
7. Adequate organ function and reserve, meeting the following laboratory criteria within 7 days prior to screening (inclusive):
HB ≥ 90 g/dL, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L; BIL < 1.5 × ULN, ALT and AST < 2.5 × ULN; ALT and AST < 5 × ULN in the presence of liver metastases; Serum Cr ≤ 1 × ULN, creatinine clearance > 50 mL/min (calculated using the Cockcroft-Gault formula); International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; for patients on anticoagulant therapy, PT within the intended therapeutic range is acceptable;
8.
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 NCT07544784, registered by Fudan 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.