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New treatment option for Colorectal Neoplasms Malignant
Official title Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.
ClinicalTrials.gov ID: NCT06778382
What this study is testing
What is Oligometastasis Treatment?
Oligometastasis Treatment is an investigational medicine, being studied as a potential treatment for colorectal neoplasms malignant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- First diagnosis of advanced colorectal cancer with metastatic disease.
- Multiple lung metastases (\> 5 lesions), liver metastasis, bone metastasis, or lymph node metastasis.
- Lung metastases that are not amenable to radiotherapy, as determined by the investigator.
- Previously received second-line or higher systemic treatment.
- Liver or kidney dysfunction: Alanine aminotransferase (ALT) \> 3 times the upper limit of normal; Aspartate aminotransferase (AST) \> 3 times the...
- Elevated tumor marker: CEA ≥ 50 ng/mL.
See the full eligibility criteria
- 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...
- 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...
- 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.
- First diagnosis of advanced colorectal cancer with metastatic disease.
- Multiple lung metastases (\> 5 lesions), liver metastasis, bone metastasis, or lymph node metastasis.
- Lung metastases that are not amenable to radiotherapy, as determined by the investigator.
- Previously received second-line or higher systemic treatment.
- 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...
- Elevated tumor marker: CEA ≥ 50 ng/mL.
- 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.
- Clinically significant central nervous system dysfunction.
- Recent major surgery (excluding lymph node biopsy) within the last 30 days.
- Pregnant or breastfeeding women of childbearing age who are not using contraception.
- Drug allergy to study treatments.
- Other reasons, as determined by the researchers, that make the patient unsuitable for participation.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.