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Compares treatment options for Colorectal Cancer
Official title Comparing 18F-FAPI PET-Guided Abdominal Radiotherapy Combined With Second-Line Standard Therapy and Cadonilimab Versus Second-Line Standard Therapy in Colorectal Cancer With Peritoneal Metastasis
ClinicalTrials.gov ID: NCT07079462
What this study is testing
What is Radiotherapy followed by immunotherapy and chemotherapy?
Radiotherapy followed by immunotherapy and chemotherapy is an investigational medicine, given as an once-daily, 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
- Main objective: 1\. To compare the objective response rate (ORR) of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib and second-line standard treatment in the treatment of peritoneal metastasis of 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
- 1\. Age of 18 years or older. 2. Peritoneal metastasis of colorectal cancer confirmed by histological or cytological examination (International Union...
- 3\. Progression after receiving standard first-line treatment before enrollment; but excluding any type of immunotherapy.
- 4\. Eastern Cooperative Oncology Group (ECOG) score of 0-1, with an expected survival time of more than 6 months.
- 5\. ECOG score of 0-1. 6. Expected survival time of ≥ 24 weeks. 7. Laboratory tests for bone marrow, liver and kidney organ functions and coagulation...
- 8\. Women with reproductive capacity must have a negative blood pregnancy test result within 7 days before the first administration. Male or female...
You likely can't join if
- 1\. Absolute neutrophil count (ANC) \< 1.5 × 109/L, or platelet count \< 100 × 109/L (for patients with liver metastasis, platelet count \< 80 ×...
- 2\. Serum total bilirubin \> 1.5 times the upper limit of normal (ULN); for patients with liver metastasis, \> 2.5 times ULN.
- 3\. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2.5 times ULN, or for patients with liver metastasis, ALT and/or AST \> 5...
- 4\. Serum creatinine \> 1.5 times ULN, or creatinine clearance rate \< 50 ml/min (calculated according to the Cockcroft-Gault formula).
- 5\. Partial thromboplastin time (APTT) or prothrombin time (PT) \> 1.5 times ULN (based on the normal values of the clinical trial center).
- 6\. The researcher determines clinically significant severe electrolyte abnormalities.
See the full eligibility criteria
- 1\. Age of 18 years or older. 2. Peritoneal metastasis of colorectal cancer confirmed by histological or cytological examination (International Union Against Cancer 8th edition of colorectal cancer staging).
- 3\. Progression after receiving standard first-line treatment before enrollment; but excluding any type of immunotherapy.
- 4\. Eastern Cooperative Oncology Group (ECOG) score of 0-1, with an expected survival time of more than 6 months.
- 5\. ECOG score of 0-1. 6. Expected survival time of ≥ 24 weeks. 7. Laboratory tests for bone marrow, liver and kidney organ functions and coagulation function within 7 days before the first administration were in...
- 8\. Women with reproductive capacity must have a negative blood pregnancy test result within 7 days before the first administration. Male or female patients with reproductive capacity voluntarily use effective...
- 9\. Voluntary enrollment and signing of informed consent form, following the trial treatment plan and visit schedule.
- 1\. Absolute neutrophil count (ANC) \< 1.5 × 109/L, or platelet count \< 100 × 109/L (for patients with liver metastasis, platelet count \< 80 × 109/L), or hemoglobin \< 9 g/dL; blood transfusion within 2 weeks prior to...
- 2\. Serum total bilirubin \> 1.5 times the upper limit of normal (ULN); for patients with liver metastasis, \> 2.5 times ULN.
- 3\. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2.5 times ULN, or for patients with liver metastasis, ALT and/or AST \> 5 times ULN.
- 4\. Serum creatinine \> 1.5 times ULN, or creatinine clearance rate \< 50 ml/min (calculated according to the Cockcroft-Gault formula).
- 5\. Partial thromboplastin time (APTT) or prothrombin time (PT) \> 1.5 times ULN (based on the normal values of the clinical trial center).
- 6\. The researcher determines clinically significant severe electrolyte abnormalities.
- 7\. Urine protein test of 2+ or above, or 24-hour urine protein quantification ≥ 1.0 g/24h.
- 8\. Hypertension that is not well controlled by medication, defined as: systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg.
- 9\. The patient currently has active peptic ulcer, ulcerative colitis, or other digestive tract diseases or active bleeding from an unresected tumor, or the researcher determines that it may cause gastrointestinal...
- 10\. Within 6 months before enrollment, there is a history of arterial thrombosis or deep vein thrombosis, or within 2 months before enrollment, there is evidence or history of bleeding tendency or history of bleeding...
- 11\. Within 12 months before enrollment, a stroke event or transient ischemic attack occurred.
- 12\. Within 6 months before enrollment, heart disease including congestive heart failure, acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass surgery; or NYHA class 2 or above heart...
- 13\. Uncontrolled malignant pleural effusion, ascites or pericardial effusion (defined as not being effectively controlled by diuretics or puncture as determined by the researcher).
- 14\. Any patient who has received any anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody (or any other antibody acting on the T cell...
- 15\. Within 4 weeks before enrollment, received any form of radiotherapy. 16. At the screening stage, there is a clinically detectable second primary malignant tumor, or other malignant tumors occurred in the past 5...
- 17\. Known clinical significance of liver disease history, including but not limited to known hepatitis B virus (HBV) infection and positive HBV DNA (≥ 1 × 104/ml); known hepatitis C virus (HCV) infection and positive...
- 18\. Pregnant or lactating women or women with a possibility of pregnancy who have a positive pregnancy test before the first medication; or female participants who are unwilling to implement strict contraception during...
- The researcher considers that the subject has any clinical or laboratory abnormalities or non-compliance issues that make them unsuitable to participate in this clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
- 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, Shanghai Municipality, China; 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.