Locally advanced rectal adenocarcinoma
Conditions
Interventions
Experimental Group:Fruquintinib combined with CAPEOX
Sponsors
Second Xiangya Hospital of CSU
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Fully understand and voluntarily sign the informed consent for this study; 2.Age 18-75 years old (including 18 and 75 years old); 3.Male or female; 4.Locally advanced rectal adenocarcinoma confirmed by histopathology; 5.Clinical stage II (T3N0) or stage III (T1-3N1-2) (according to AJCC 8th) by preoperative pelvic MRI or transrectal ultrasonography; 6.The tumor should be evaluated as resectable; 7.The tumor lesions should be examined by digital rectal examination or colonoscopy; 8.The lower margin of the tumor lesion is within 12cm of the anal verge; 9.No previous systemic antineoplastic therapy; 10.At least one radiographic measurable lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); 11.ECOG performance status 0-1; 12.Expected survival >=12 weeks; 13.Adequate organ and bone marrow function and laboratory values within 14 days prior to enrollment (no administration of blood components, cell growth factors, albumin, or other corrective medications within 14 days prior to laboratory testing) will be required as follows: (1) Blood routine: Absolute neutrophil count(ANC) >=1.5×10^9/L; Platelet count(PLT) >=100×10^9/L;Hemoglobin(HGB) >=9.0g/dL; (2) Liver function: Total bilirubin(TBIL) =50ml/min(Cockcroft-Gault); Urine routine test showed urinary protein=2+ at baseline, 24-hour urine collection should be performed and 24-hour urinary protein quantification <1.0g. (4) Coagulation function:International normalized ratio (INR) and partial activated prothrombin time (APTT) <=1.5×ULN. 14.Female patients of childbearing age or male patients whose sexual partner is a female of childbearing age should take effective contraceptive measures during the whole treatment period and 6 months after the last treatment.
Exclusion criteria
Exclusion criteria: 1.Patients with other malignant tumors within 5 years before enrollment, except skin basal cell or squamous cell carcinoma after radical operation, or cervical carcinoma in situ; 2.The clinical stage of the tumor was cT4; 3.MSI-H or dMMR; 4.Patients with pelvic invasion; 5.Patients with distant metastasis; 6.History of rectal malignancies including sarcoma, lymphoma, carcinoid, and squamous cell tumors; 7.Allergy to study medication; 8.Drug-uncontrolled hypertensions: systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg; history of hypertensive crisis or hypertensive encephalopathy. 9.Clinically significant electrolyte disturbances; 10.Clinically uncontrolled active infection, such as acute pneumonia, active hepatitis B or hepatitis C (For patients with previous hepatitis B virus infection history , HBV DNA.=104 × copy number or >=2000IU/mL no matter it was controlled by medication or not). 11.Patients have severe lung diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.) within 4 weeks before inclusion; 12.Patients with complicated mental disorders affecting clinical treatment or a past history of central nervous disorders; 13.With dysphagia or known malabsorption of drugs; 14.Patients with active gastric or duodenal ulcer, ulcerative colitis, intestinal obstruction, other gastrointestinal diseases, or active bleeding from unresectable tumor before enrollment, or other conditions that may cause gastrointestinal bleeding or perforation as judged by the investigator before enrollment; Or have a history of bowel perforation or fistula and do not fully recover from surgery before enrollment. 15.Patients had a history of arterial or deep-vein thrombosis within 6 months before enrollment or evidence or history of bleeding tendency, regardless of severity, within 2 months before enrollment. 16.Stroke or transient ischemic attack occurred within 12 months before enrollment. 17.Incomplete healing of skin wounds, surgical sites, trauma sites, severe mucosal ulcers, or fractures. 18.Acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months before enrollment; New York Heart Association (NYHA) classification> Grade 2 . 19.Pregnant or lactating women, or female subjects of childbearing potential who had a positive pregnancy test before the first study administration. Women or men who refuse to use contraception. 20.Patients receiving other antineoplastic therapy (including tumor immunotherapy, interventional therapy, and intravenous antineoplastic drugs) or participating in other interventional clinical trials; 21.Have participated in any other drug clinical trial within the past 4 weeks. 22.Any clinical or laboratory abnormalities or adherence that were deemed by the investigator to be inappropriate for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete Response (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rates(DCR) before surgery;R0 resection rate;Tumor downstaging status;Tumor regression (TRG grade);Disease-free survival (DFS);3-year disease free survival rate (DFS);3-year local recurrence rate;3-year recurrence with distant metastasis rate;overall survival (OS);objective response rate (ORR) before surgery;adverse events (AE); | — |
Countries
China
Contacts
Public ContactHongliang Yao
Second Xiangya Hospital of CSU
Outcome results
None listed