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New treatment option for Colorectal Cancer
Official title Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases
ClinicalTrials.gov ID: NCT06356584
What this study is testing
What is Immunotherapy (Sintilimab)?
Immunotherapy (Sintilimab) is an investigational medicine, being studied as a potential treatment for colorectal cancer.
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 a significant cause of morbidity and mortality worldwide. Its early clinical manifestations are often subtle, leading to late-stage diagnosis in about 30% of cases with distant metastases.
- 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
- ECOG PS 0-2
- Histologically confirmed colorectal adenocarcinoma with liver metastases (8th edition AJCC)
- MSS/pMMR subtype
- Previously received standard first- and second-line systemic anti-tumor therapy
- At least one measurable lesion as defined by RECIST 1.1 criteria
You likely can't join if
- Patients diagnosed with malignancies other than colorectal cancer within 3 years prior to enrollment.
- Participating in an treatment clinical study or receiving other investigational drugs or treatments with study devices within the past 4 weeks before...
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another T cell co-stimulatory or...
- Received traditional Chinese medicine or immune-modulating drugs with anti-tumor indications within the past 2 weeks before enrollment (excluding...
- Experienced active autoimmune diseases requiring systemic therapy within the past 2 years before enrollment. Replacement therapy is not considered...
- Diagnosed with immune deficiency or received systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days before the...
See the full eligibility criteria
- ECOG PS 0-2
- Histologically confirmed colorectal adenocarcinoma with liver metastases (8th edition AJCC)
- MSS/pMMR subtype
- Previously received standard first- and second-line systemic anti-tumor therapy
- At least one measurable lesion as defined by RECIST 1.1 criteria
- Access to tumor samples for biomarker assessment
- Expected survival of ≥3 months
- Normal function of major organ systems (within 14 days before enrollment)
- No systemic corticosteroid treatment within 7 days before treatment initiation, excluding physiological corticosteroid replacement therapy.
- Fertile males or females with the potential for pregnancy must use highly effective contraception methods during the trial.
- Patients diagnosed with malignancies other than colorectal cancer within 3 years prior to enrollment.
- Participating in an treatment clinical study or receiving other investigational drugs or treatments with study devices within the past 4 weeks before enrollment.
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another T cell co-stimulatory or co-inhibitory receptor (e.g., CTLA-4, OX-40, CD137), fruquintinib, etc.
- Received traditional Chinese medicine or immune-modulating drugs with anti-tumor indications within the past 2 weeks before enrollment (excluding local use for controlling pleural effusion).
- Experienced active autoimmune diseases requiring systemic therapy within the past 2 years before enrollment. Replacement therapy is not considered systemic therapy.
- Diagnosed with immune deficiency or received systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of investigational treatment. After consultation with the...
- Received liver radiotherapy within the past 2 weeks before enrollment.
- Known presence of central nervous system metastases and/or carcinomatous meningitis.
- Received systemic corticosteroid therapy within 7 days before enrollment.
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.