Actively Recruiting
Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.
Led by Shandong Cancer Hospital and Institute · Updated on 2026-04-28
22
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed colorectal cancer diagnosis
- Achieved No Evidence of Disease (NED) after EMR, surgery, radiofrequency ablation, or radiotherapy
- Maintained NED for at least 6 months
- No prior or only postoperative adjuvant or first-line systemic chemotherapy received
- Have 5 or fewer lung oligometastatic lesions eligible for destructive therapy
- No previous lung radiotherapy
- Measurable lesions per RECIST 1.1 criteria
- ECOG performance status of 2 or less
- Expected survival of at least 3 months
- Adequate blood counts without recent growth factor support
- Normal organ function to tolerate local destructive treatment
- Female patients of childbearing potential agree to reliable contraception during study and 1 year after
- Provided informed consent voluntarily
You will not qualify if you...
- Advanced colorectal cancer with metastatic disease at first diagnosis
- More than 5 lung metastases, or liver, bone, or lymph node metastases
- Lung metastases not suitable for radiotherapy
- Previous second-line or higher systemic treatment
- Significant liver or kidney dysfunction beyond defined limits
- Elevated tumor marker CEA level 50 ng/mL or higher
- Serious medical conditions interfering with study participation
- Severe or uncontrolled infections
- Active autoimmune disease
- Significant central nervous system dysfunction
- Major surgery (except lymph node biopsy) within 30 days
- Pregnant or breastfeeding women not using contraception
- Allergy to study treatments
- Other reasons deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Radiation Oncology, Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 0531
Actively Recruiting
Research Team
J
Jinbo Yue, Dorcter
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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