NCT06778382RecruitingPhase 2
Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.
Deferred Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After NED in Colorectal Cancer： A Phase II, Single-Arm Clinical Trail.
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 12 Jan 2025
- Start date
- 24 Jun 2024
- Primary completion date
- 1 Nov 2025
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Diseases
- Lung cancer, Colorectal cancer
- NCT number
- NCT06778382
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 35
- From 24 Jun 2024 to the primary completion date, 1 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Lung metastases that are not amenable to radiotherapy, as determined by the investigator.
- Previously received second-line or higher systemic treatment.
- Recent major surgery (excluding lymph node biopsy) within the last 30 days.
Other illness
- First diagnosis of advanced colorectal cancer with metastatic disease.
- Serious medical conditions that may interfere with the study (e.g., uncontrolled diabetes, gastric ulcers, severe cardiopulmonary diseases), at the discretion of the researchers.
- Severe or uncontrolled infections.
- Active autoimmune disease.
- Drug allergy to study treatments.
Lab values
- Liver or kidney dysfunction: Alanine aminotransferase (ALT) \> 3 times the upper limit of normal; Aspartate aminotransferase (AST) \> 3 times the upper limit of normal; Total bilirubin (TBIL) \> 2 times the upper limit of normal; Serum creatinine \> 1.5 times the upper limit of normal.
Age
- Pregnant or breastfeeding women of childbearing age who are not using contraception.
Other
- Multiple lung metastases (\> 5 lesions), liver metastasis, bone metastasis, or lymph node metastasis.
- Elevated tumor marker: CEA ≥ 50 ng/mL.
- Clinically significant central nervous system dysfunction.
- Other reasons, as determined by the researchers, that make the patient unsuitable for participation.
Who the study is looking for
- Patients with a pathologically confirmed diagnosis of colorectal cancer with the following disease conditions:
- The patient has achieved No Evidence of Disease (NED) after undergoing EMR, surgery, radiofrequency ablation, or radiotherapy.
- NED has been maintained for ≥ 6 months.
- The patient has not received chemotherapy, or has only received postoperative adjuvant chemotherapy or first-line systemic therapy.
- Oligometastatic lung lesions (defined as 5 or fewer lesions) detected after ≥ 6 months of NED maintenance, eligible for destructive therapy.
- 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.
- Reproductive age: Female patients of childbearing potential must agree to use a reliable method of contraception with their partner from the time of informed consent until 1 year after treatment completion.
- The patient must have voluntarily provided informed consent to participate in the study.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Radiation Oncology, Shandong Cancer Hospital and Institute Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.