Safety of Cetuximab and Trifluridin Tipiracil as the Third-line Therapy in the RASwt mCRC

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This was a single-arm, prospective study to investigate the safety of cetuximab in combination with trifluridin tipiracil (TAS-102) in the third-line treatment of Chinese patients with RAS wild-type mCRC.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

1.18-75 years old male or female; 2. Histologically or cytologically confirmed metastatic colon or rectal adenocarcinoma; excluding appendiceal cancer and anal canal cancer; 3. 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; 4. ECOG PS 0-1; 5. 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); 6. RAS gene mutation detection results are wild-type. The test sample can be the primary tumor or metastasis sample; 7. Can receive oral drug treatment; 8. 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); (6) Total bilirubin ≤ 1.5 × UNL; (7) Creatinine clearance (calculated according to Cockcroft and Gault formula) > 60 mL/min or serum creatinine ≤ 1.5 × UNL; 9. Expected survival time > 3 months (90 days); 10. 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; 11. The patients voluntarily participated in this study and signed the informed consent form, with good compliance and cooperation in the follow-up.

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Exclusion Criteria:

1. Previously treated with regorafenib, fruquintinib, TAS-102;

2. Participated in another drug clinical trial in the past 4 weeks, or received systemic chemotherapy, radiotherapy or biological therapy in the past 4 weeks;

3. Known brain metastases or strongly suspected brain metastases;

4. Patients with known BARF mutations should be excluded;

5. 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;

6. 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;

7. Serosal effusion (including pleural effusion, ascites, pericardial effusion) with clinical symptoms and requiring symptomatic treatment;

8. Pregnant or lactating women; patients of childbearing potential are unwilling or unable to take effective contraceptive measures;

9. Known to be allergic to the study drug, study drug class and its ingredients;

10. Conditions requiring systemic steroid treatment (except topical steroid and cetuximab pretreatment);

11. History of interstitial lung disease (interstitial pneumonia, pulmonary fibrosis, etc.) or CT findings of interstitial lung disease;

12. Active local or systemic infection requiring treatment;

13. Cardiac function classification (NYHA classification) ≥ Grade III or severe heart disease;

14. Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) or active hepatitis B, C;

15. Toxicity not recovered (CTCAE > grade 1) or not completely recovered from previous anticancer surgery;

16. Patients judged by the Investigator as unsuitable for this study -