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Recruiting Phase 2

TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer

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About this study

This study is a randomized, controlled, open-label, multicentre clinical study. This study is designed to evaluate the efficacy and safety of TAS-102 combined with bevacizumab as second-line maintenance therapy versus standard chemotherapy combined with bevacizumab as second-line continuous therapy in advanced colorectal cancer after second-line induction therapy.

Condition
Colorectal Cancer
Tested
TAS-102+bevacizumab, Standard chemotherapy+bevacizumab
Sponsor
Henan Cancer Hospital

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 16

  • Minimum age: 18 years
  • Study condition: Colorectal Cancer
  • Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance;
  • Age ≥18 years old;
  • Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology;
  • After receiving 12 weeks of standard chemotherapy (FOLFOX, FOLFIRI, or CAPEOX) combined with bevacizumab second-line induction therapy, the patients are confirmed as CR, PR, or SD according to RECIST 1.1 criteria;
  • The interval between the last second-line induction therapy and randomization is not more than 6 weeks;
  • At least one measurable lesion according to RECIST 1.1 criteria;
  • ECOG Performance Status 0-2;
  • Estimated life expectancy ≥12 weeks;
  • Adequate major organ function (no medication for blood component, cell growth factor correction therapy is allowed within 14 days before randomization);
  • Women of child-bearing potential must agree to abstain from sex (heterosexual intercourse) or use a reliable, effective method of contraception from the time they provide informed consent until at least 90 days after the last dose of study drug is administered.
  • Serum or urine HCG test must be negative.
  • And must be non-lactating;
  • Male participants whose partner is a woman of child-bearing potential must agree to abstain from sex or use a reliable,effective method of contraception from the time they sign an informed consent form until at least 90 days after the last dose of study drug is administered.
  • Male subjects also have to agree not to donate sperm during the same period.

Exclusion 22

  • Any CTCAE grade 1 or above toxicity caused by previous treatment that has not yet subsided (excluding alopecia, skin pigmentation, and chemotherapy-induced neurotoxicity);
  • Known history or evidence of interstitial lung disease or active noninfectious pneumonia;
  • Poorly controlled hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg) with a previous history of hypertensive crisis or hypertensive encephalopathy;
  • Have bleeding tendency and high risk of bleeding;
  • Known inherited or acquired bleeding (e.g., coagulopathy) or thrombophilia, as in patients with hemophilia;
  • Current or recent (within 10 days before initiation of study treatment) use of a full-dose oral or injectable anticoagulant or thrombolytic agent for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed);
  • Thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc., occurred within 6 months before the initiation of study treatment;
  • Severe, unhealed or dehiscence wounds and active ulcers or untreated fractures;
  • Has undergone major surgical treatment (excluding diagnosis) within 4 weeks before the start of the study or is expected to undergo major surgical treatment during the study period;
  • Inability to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption;
  • Patients with congenital or acquired immune deficiency (such as HIV infection);
  • Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA≥2000 IU/ml; Hepatitis C reference: HCV antibody positive and HCV virus copy number \> upper limit of normal);
  • Known brain and/or leptomeningeal metastases. All subjects should receive brain CT/MRI to exclude brain metastases;
  • Active infection or fever of unknown origin \> 38.5 ° C within 2 weeks before the first dose (tumor-related fever, as judged by the investigator, was eligible);
  • Acute or subacute intestinal obstruction, or chronic inflammatory bowel disease;
  • Have poorly controlled cardiac clinical symptoms or disease；
  • Patients with other malignant tumors within 5 years before enrollment, except basal cell carcinoma of the skin or carcinoma in situ of the cervix;
  • Pregnant or lactating women;
  • Patients with genotype MSI-H;
  • Prior treatment with TAS-102;
  • Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before study treatment;
  • The investigator assessed that it is not appropriate to participate in the study.

Where

1 site, 1 recruiting

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.