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New treatment option for Colorectal Cancer
Official title Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT07398326
What this study is testing
What is anlotinib and sintilimab?
anlotinib and 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 the third most common malignant tumor worldwide and the second leading cause of cancer-related deaths. Despite recent progress in CRC research, approximately 15% to 30% of patients have metastatic lesions at the time of initial diagnosis, and another 20% to 50% of patients with primary localized CRC eventually develop metastatic disease.
- 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 and older
You may be able to join if
- Patients with histologically or cytologically confirmed advanced colorectal adenocarcinoma.
- Patients with non-hepatic metastases who explicitly refuse chemotherapy.
- Patients who have not received prior systemic therapy, or those with metastasis or recurrence occurring ≥12 months after completion of adjuvant...
- At least one measurable lesion according to RECIST 1.1 criteria.
- Prior local radiotherapy is permitted if completed at least 3 weeks before the first study drug administration; however, lesions used for RECIST...
You likely can't join if
- Patients who have undergone major surgery or sustained severe trauma within 4 weeks prior to the first dose of the study drug.
- Patients with a history of hypersensitivity to any component of the study regimen.
- Patients who are planning to conceive, are pregnant.
- Patients with brain metastases who are unable to accurately describe their symptoms or condition.
- Patients with a history of autoimmune diseases or organ transplantation.
- Use of immunosuppressive medications within 2 weeks prior to the initiation of study treatment (excluding inhaled corticosteroids, or physiological...
See the full eligibility criteria
- Patients with histologically or cytologically confirmed advanced colorectal adenocarcinoma.
- Patients with non-hepatic metastases who explicitly refuse chemotherapy.
- Patients who have not received prior systemic therapy, or those with metastasis or recurrence occurring ≥12 months after completion of adjuvant therapy.
- At least one measurable lesion according to RECIST 1.1 criteria.
- Prior local radiotherapy is permitted if completed at least 3 weeks before the first study drug administration; however, lesions used for RECIST evaluation must be outside the radiation field.
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- Ability to understand and voluntarily provide written informed consent.
- For women of childbearing potential, a negative pregnancy test within 7 days prior to treatment initiation. Both patients and their partners must agree to use effective contraception during the study period.
- Patients who have undergone major surgery or sustained severe trauma within 4 weeks prior to the first dose of the study drug.
- Patients with a history of hypersensitivity to any component of the study regimen.
- Patients who are planning to conceive, are pregnant.
- Patients with brain metastases who are unable to accurately describe their symptoms or condition.
- Patients with a history of autoimmune diseases or organ transplantation.
- Use of immunosuppressive medications within 2 weeks prior to the initiation of study treatment (excluding inhaled corticosteroids, or physiological replacement doses of steroids equivalent to ≤10 mg/day of prednisone).
- Administration of a live attenuated vaccine within 4 weeks prior to the start of study treatment or planned vaccination during the study period.
- Prior treatment with anlotinib, anti-PD-1/PD-L1 monoclonal antibodies, or any other therapy targeting T-cell co-stimulation or immune checkpoint pathways.
- History of any of the following within 6 months before starting study treatment: myocardial infarction, severe/unstable angina, congestive heart failure of New York Heart Association (NYHA) Class 2 or higher, or poorly...
- Laboratory test abnormalities meeting any of the following criteria:
- Absolute neutrophil count (ANC) \<1,500/mm³.
- Platelet count \<75,000/mm³.
- Total bilirubin \>1.5 times the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2.5 times ULN.
- Serum creatinine \>1.5 times ULN.
- Diagnosis of any malignancy other than advanced colorectal cancer within the 5 years preceding the start of study treatment, except for carcinoma in situ of the cervix, cured basal cell carcinoma, or bladder epithelial...
- Patients with colorectal cancer amenable to curative surgical resection (however, those who explicitly refuse surgery or are deemed unsuitable for surgery may be eligible).
- History of substance abuse, drug use, or alcohol dependence.
- Lack of legal capacity or limited civil capacity.
- Any other condition that, in the opinion of the Investigator, makes the patient unsuitable for study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, 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.