| Eligibility |
Inclusion Criteria:
- 18-75 years old male or female;
- Histologically or cytologically confirmed metastatic colon or rectal adenocarcinoma;
excluding appendiceal cancer and anal canal cancer;
- Previously received second-line treatment, at least 2 standard chemotherapy
regimens(including fluorouracil, capecitabine, irinotecan, oxaliplatin, raltitrexed
and anti-VEGF, anti-EGFR, etc.), if already accepted anti-EGFR treatment achieved at
least PR or above;
- ECOG PS 0-1;
- At least one measurable lesion by CT or MRI (according to RECIST 1.1 criteria, the
longest diameter of tumor lesion CT/MRI scan = 10 mm, lymph node lesion CT/MRI scan
shortest diameter = 15 mm);
- RAS gene mutation detection results are wild-type. The test sample can be the primary
tumor or metastasis sample;
- Can receive oral drug treatment;
- Normal function of major organs, meeting the following criteria within 14 days before
the start of treatment:
1. neutrophil count = 1.5 × 10*9/L;
2. Platelet count = 75 × 10*9/L;
3. Hemoglobin = 9.0 g/dL;
4. AST = 2.5 × UNL (upper limit of normal) (if liver metastasis AST = 5 × UNL);
5. ALT = 2.5 × UNL (if liver metastasis AST = 5 × UNL);
g.Creatinine clearance (calculated according to Cockcroft and Gault formula) > 60
mL/min or serum creatinine = 1.5 × UNL;
- Expected survival time > 3 months (90 days);
- Women of childbearing potential must have used reliable contraception and had a
negative pregnancy test within 7 days prior to enrollment and be willing to use an
appropriate method of contraception during the trial and for 6 months after the last
dose of trial drug. Males must agree to use an adequate method of contraception or
have been surgically sterilized during the trial and for 6 months after the last dose
of trial drug;
- The patients voluntarily participated in this study and signed the informed consent
form, with good compliance and cooperation in the follow-up.
Exclusion Criteria:
- Previously treated with regorafenib, fruquintinib, TAS-102;
- Participated in another drug clinical trial in the past 4 weeks, or received systemic
chemotherapy, radiotherapy or biological therapy in the past 4 weeks;
- Known brain metastases or strongly suspected brain metastases;
- Patients with known BARF mutations should be excluded;
- Synchronous cancer or metachronous cancer with disease-free survival = 5 years (except
colorectal cancer), excluding mucosal cancer (esophageal cancer, gastric cancer,
cervical cancer, non-melanoma skin cancer, bladder cancer, etc.) that has been cured
or may be cured by local resection;
- Factors that significantly affect the absorption of oral drugs, such as inability to
swallow, chronic diarrhea and gastric intestinal obstruction; ucontrolled Crohn's
disease or ulcerative colitis;
- Serosal effusion (including pleural effusion, ascites, pericardial effusion) with
clinical symptoms and requiring symptomatic treatment;
- Pregnant or lactating women; patients of childbearing potential are unwilling or
unable to take effective contraceptive measures;
- Known to be allergic to the study drug, study drug class and its ingredients;
- Conditions requiring systemic steroid treatment (except topical steroid and cetuximab
pretreatment);
- History of interstitial lung disease (interstitial pneumonia, pulmonary fibrosis,
etc.) or CT findings of interstitial lung disease;
- Active local or systemic infection requiring treatment;
- Cardiac function classification (NYHA classification) = Grade III or severe heart
disease;
- Known history of human immunodeficiency virus (HIV) infection or acquired
immunodeficiency syndrome (AIDS) or active hepatitis B, C;
- Toxicity not recovered (CTCAE > grade 1) or not completely recovered from previous
anticancer surgery;
- Patients judged by the Investigator as unsuitable for this study.
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