Recruiting nowPhase 2
| Registry number | NCT06778382 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 22 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Shandong Cancer Hospital and Institute |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Combination product Oligometastasis Treatment
What it is measuring
Time Without Systemic Therapy
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 researchers are testing whether destructive local treatment of a small number of colorectal cancer metastases in the lungs can control the visible disease well enough for patients who otherwise have no evidence of disease to delay restarting systemic chemotherapy. The trial asks whether this treatment-first approach can keep patients free from systemic therapy for longer.
The idea is to avoid or postpone chemotherapy when all detectable lung metastases have been treated locally, potentially reducing treatment burden and side effects. The measured improvement is time without systemic therapy, not longer survival or proof that the cancer will not return.
Worth knowing: This is a small, non-randomised phase 2 study with no comparison group, and its main outcome is time without systemic therapy rather than survival.
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
Colorectal cancer (CRC) is the third most common cancer worldwide. Surgical resection is one of the primary treatment options for CRC; however, postoperative recurrence remains a significant clinical challenge for both the medical community and patients. Postoperative chemotherapy, as an important adjuvant therapy, is widely used in CRC patients aiming to reduce the risk of recurrence. Despite extensive research on the efficacy of postoperative chemotherapy in CRC, the mechanisms of postoperative recurrence, predictive factors, and strategies to enhance chemotherapy effectiveness remain unclear. For colorectal cancer patients who have achieved NED (No Evidence of Disease), the decision to either reinitiate or change the systemic chemotherapy regimen for newly developed pulmonary oligometastases remains controversial. Local treatment options for diagnosing oligometastases include surgery, radiotherapy, and radiofrequency ablation. However, whether systemic treatment should be added after local treatment in patients who have achieved NED remains uncertain , and this issue requires urgent resolution.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- 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
- Patients with a pathologically confirmed diagnosis of colorectal cancer with the following disease conditions:
1. The patient has achieved No Evidence of Disease (NED) after undergoing EMR, surgery, radiofrequency ablation, or radiotherapy.
2. NED has been maintained for ≥ 6 months.
3. The patient has not received chemotherapy, or has only received postoperative adjuvant chemotherapy or first-line systemic therapy.
4. Oligometastatic lung lesions (defined as 5 or fewer lesions) detected after ≥ 6 months of NED maintenance, eligible for destructive therapy.
5. No prior radiotherapy to the lungs.
- RECIST 1.1 criteria: The patient must have measurable lesions, defined as at least one nodal lesion with a longest diameter > 1.5 cm, or at least one nodal lesion > 1 cm with an accurately measurable pendulous diameter.
- ECOG performance status: ≤ 2 (Eastern Cooperative Oncology Group general condition score).
- The patient's expected survival must be ≥ 3 months.
- Adequate hematologic function: Absolute neutrophil count ≥ 1.6 x 10⁹/L, with no growth factor support for at least 7 days prior to testing.
- Normal organ function: The patient must be able to tolerate at least one of the local destructive treatments, as assessed by the corresponding department's physician, based on normal hepatic, renal, pulmonary, and cardiac function.
- Reproducti…
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 NCT06778382, registered by Shandong Cancer Hospital and Institute 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.