Last updated: July 19, 2022
Sponsor: Tongji Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Colon Cancer
Colorectal Cancer
Treatment
N/AClinical Study ID
NCT05468177
TJ-IRB20220165
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- RAS and BARF wild-type right colon adenocarcinoma (cecum, ascending colon, transversecolon excluding splenic flexure) confirmed by histopathology;
- Locally advanced right colon cancer should be assessed as T3 (invading muscularispropria ≥5mm) or T4 according to abdominal CT;
- Metastatic right colon cancer should conforms to the definition of oligometastasis ofcolorectal cancer in ESMO guidelines: the number of organs involved is ≤2 (occasionally 3), and the number of metastases is usually ≤5 or occasionally more.
- At least one measurable lesion according to RECIST1.1;
- ECOG score 0-1;
- The expected survival time is more than 3 months;
- Adequate organ function: total bilirubin ≤1.5 x upper limit of normal (ULN) ,aspartate aminotransferase and alanine aminotransferase ≤2.5 x ULN (if patient withliver metastasis, total bilirubin ≤3 x ULN, aminotransferase and alanineaminotransferase ≤5x ULN) ,alkaline phosphatase ≤2.5 x ULN (if liver metastases≤5xULN, if bone metastases ≤10 x ULN);LDH < 1500 U/L;Serum creatinine≤1.5 x ULN l orcreatinine clearance rate ≤ 60 mL /min;ANC≥1.5×109 /L, platelet count ≥75×109 /L, Hb ≥90 g/L, WBC ≥3.0×109 /L;
- Capable of providing informed consent, or if not capable, a legally authorizedrepresentative is capable of providing informed consent.
Exclusion
Exclusion Criteria:
- 1.Early stage right colon cancer. 2. Received chemotherapy or biotherapy in the past .
- uncontrollable infection, or received antibiotic treatment within 72 hours prior toreceive chemotherapy; 4. Myelodysplastic syndrome or other hematopoieticabnormalities; 5. Other malignant tumors (except carcinoma in situ and basal cellcarcinoma) during this year; 6. Patients with central nervous system metastasis; 7.≥CTCAE Grade 2 unrecovered AEs due to prior treatment (excluding anemia, hair loss,skin pigmentation).Patients with unrecovered neurotoxicity ≥ CTCAE grade 3 due toplatinum-based drugs.
- Other diseases, such as active tuberculosis, infect HIV, AIDS, hepatitis B (patientwithHBV-DNA <500IU/ml,and normal liver function can be included), positive test forhepatitis C virus, uncorrectable electrolyte disorder;ascites, pleural effusion orhydropericardium that required drainage in the past 4 weeks.With intestinalobstruction, gastrointestinal bleeding, pulmonary fibrosis or interstitial pneumonia,renal failure, hepatic failure , or cerebrovascular disease.
- Uncontrolled diabetes was defined as HbA1c >7.5% after the use of antidiabeticdrugs, or uncontrolled hypertension was defined as systolic/diastolic blood pressure >140/90 mmHg after the use of antihypertensive drugs.
- Myocardial infarction,severe/unstable angina, NYHA III or IV congestive heartfailure within the past 12 months.
- Patients who are allergic to the therapeutic drugs in this study; 12. With mentalor nervous system diseases who are unable to cooperate; 13. Pregnant or lactatingwomen;Childbearing age women refuse to accept contraceptive measures; 14.Activeautoimmune disease, a history of autoimmune disease, accepting corticosteroid orimmunosuppressants, or accepting hormone replacement therapy (such as thyroxine,insulin, etc).
- Received live vaccine within 30 days (seasonal influenza vaccine is allowedbecause it is inactivated) 16.Treated with any other investigational drug orparticipated in another interventional clinical trial within 30 days of the screeningperiod; undergo surgery within 30 days (except for diagnostic biopsy, surgicalincision should be completely healed prior to administration of the studydrug).Received radiation therapy within 30 days.
- Other serious medical conditions made the investigator consider the patientsineligible for inclusion.
Study Design
Total Participants: 66
Study Start date:
August 01, 2022
Estimated Completion Date:
June 30, 2025
Study Description
Connect with a study center
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei
ChinaActive - Recruiting
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