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New treatment option for Colorectal Cancer Metastatic
Official title Oral Chemotherapy, Targeted Therapy and Immunotherapy With/Without Radiotherapy as 3rd- or Later-line Therapy for Advanced MSS/pMMR Colorectal Cancer
ClinicalTrials.gov ID: NCT06764680
What this study is testing
What is Trifluorouracil tepidopyrimidine?
Trifluorouracil tepidopyrimidine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for colorectal cancer metastatic.
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
- The current phase 2, double cohort clinical trial was designed to determine the effectiveness of Trifluridine and Tipiracil Hydrochloride Tablets, Bevacizumab and Sintilimab with/without involved lesions irradiation as 3rd- or later-line therapy for advanced MSS/pMMR colorectal cancer.
- 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 advanced colorectal adenocarcinoma of MSS/pMMR confirmed by histologic or cytologic diagnosis;
- aged 18 years and older;
- have a quality of life score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG);
- can take oral medications;
- expected survival ≥ 3 months;
You likely can't join if
- prior application of trefluridine tepidopyrimidine;
- prior application of PD-1 or PD-L1 monoclonal antibody;
- extensive bone metastases;
- extensive peritoneal metastases;
- malignant hydrothorax and ascites;
- clinical or imaging signs of spinal cord compression, or dural sac tumor visible on MRI within 2 mm of the spinal cord. If surgically resectable, it...
See the full eligibility criteria
- patients with advanced colorectal adenocarcinoma of MSS/pMMR confirmed by histologic or cytologic diagnosis;
- aged 18 years and older;
- have a quality of life score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG);
- can take oral medications;
- expected survival ≥ 3 months;
- progressed after standard second-line or more than second-line therapy (received oxaliplatin, irinotecan, and fluorouracil analogs);
- have a measurable target lesion according to RECIST v1.1 evaluation criteria;
- have a number of recurrent metastatic organs ≤ 2 for all measurable lesions, a maximum diameter of recurrent metastatic lesions ≤ 5 cm, and a total number of recurrent metastatic lesions ≤ 10;
- agree to provide previously stored tumor tissue specimens or perform biopsies to collect tumor lesion tissue for biomarker analysis
- have chest, abdomen and pelvis CT or whole body PET-CT results within 4 weeks before enrollment;
- no ascites;
- having adequate major organ function, electrocardiogram, blood, biochemistry and other basic tests to exclude contraindications to chemotherapy and radiotherapy;
- hemoglobin \>8g/L, platelets ≥100×10\^9/L, neutrophils ≥1.5×10\^9/L
- for patients with liver metastases, aminotransferases and bilirubin \< 5 times the upper limit of normal;
- for patients without liver metastases, aminotransferases and bilirubin should be \<2.5 times the upper limit of normal.
- women of childbearing age must have a negative pregnancy test and conscientiously observe contraceptive measures;
- prior systemic systemic therapy and radiation therapy for other lesions are allowed;
- in case of discomfort such as obstruction, bleeding, compression and pain caused by the tumor, the clinical situation that local treatment may benefit the patient may be discussed between the doctor and the patient as...
- if radiotherapy is required, the patient can be kept in a fixed position during radiotherapy;
- If SABR treatment is required, the patient can tolerate the physical restraint of the immobilization device;
- good control of the primary site: at least 3 months from radical treatment of the primary tumor, with no disease progression at the site of the primary site; or the primary tumor is not radically treated but, in the...
- prior application of trefluridine tepidopyrimidine;
- prior application of PD-1 or PD-L1 monoclonal antibody;
- extensive bone metastases;
- extensive peritoneal metastases;
- malignant hydrothorax and ascites;
- clinical or imaging signs of spinal cord compression, or dural sac tumor visible on MRI within 2 mm of the spinal cord. If surgically resectable, it may be enrolled, but a maximum of 3 surgical sites are allowed;
- unstable brain metastases with clinical signs or imaging evidence that require surgical decompression;
- brainstem metastases;
- metastatic lesions invading any of the following structures: gastrointestinal tract (including esophagus, stomach, small intestine, large intestine), skin. Includes extensive/poppy metastatic disease (e.g., brain, bone...
- multiple intracranial metastases only;
- pregnant or lactating females;
- no reliable contraception during the reproductive period
- patients with a known history of hypersensitivity to any of the study drugs, analogs, or excipients;
- patients at risk of gastrointestinal hemorrhage or gastrointestinal obstruction;
- patients with a history of thromboembolism, with the exception of thrombosis caused by PICCs or infusion ports
- patients with difficult-to-control hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90 mmHg after optimal antihypertensive treatment);
- patients with contraindications to treatment such as other chronic diseases;
- Patients with active infections;
- patients with a pre-existing condition of immunotherapy-associated myocarditis, pneumonia, colitis, hepatitis, or nephritis who, in the judgment of the investigator, are at greater risk for reuse of immunotherapy;
- patients with existing toxic side effects ≥ grade 2 due to prior therapy according to NCI CTCAE version 5.0 (except for alopecia, hyperpigmentation, etc.);
- severe medical comorbidities that preclude radiotherapy, including interstitial lung disease with current metastases requiring radiotherapy to the lungs, Crohn's disease requiring radiotherapy to the gastrointestinal...
- there is an overlap between the current radiation field and the field of prior radiotherapy. It may be permissible to have had prior radiation therapy as long as the fusion cumulative dose meets the dose limits. For...
- prior systemic nuclide therapy, such as Radium-223 or Lutetium-177);
- other circumstances that the investigator determines are not appropriate for inclusion in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 Guangzhou, Guangdong, 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.