CompletedPhase 3

Comparison of A140 and Erbitux Combined With mfolfox6 to Evaluate Efficacy and Safety of First-line Treatment for Ras Wild-type mCRC

China688 participantsStarted 2020-12-31

Plain-language summary

Compare the objective remission rate of A140 and Erbitux combined with mfolfox6 regimen in the first-line treatment of Ras wild-type metastatic colorectal cancer for 12 weeks

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Peripheral blood cell count: leukocyte count ≥ 3×10ˆ9 / L, neutrophil count ≥ 1.5× 10ˆ9 / L, platelet count ≥ 75 × 10ˆ9 / L, hemoglobin ≥ 90 g / L;
✓. Liver function: total bilirubin ≤ 1.5 ULN, Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 ULN; AST and ALT≤ 5 ULN in subjects with liver metastasis;
✓. Renal function: serum creatinine ≤ 1.5 ULN.

Exclusion criteria

✕. Receiving other anti-tumor treatments (including anti-tumor treatments with traditional Chinese medicines, such as Aidi injection, Kanglaite injection, Kangai injection, cininobufosin, brucea javanica oil, etc.) within 4 weeks before the first administration of the study ；
✕. Long-term systemic immunotherapy, or hormone therapy for anti-tumor purposes (physiological replacement therapy, except for those with hypothyroidism who take thyroxine);
✕. Have received G-CSF, GM-CSF, whole blood or blood component transfusions within 4 weeks before the first medication of the study;
✕. Have received other experimental drugs or interventional clinical studies within 4 weeks before the first medication of the study；

What they're measuring

ORR

Timeframe: 16 Weeks

Trial details

NCT IDNCT04835142

SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-22

View on ClinicalTrials.gov More Metastatic Colorectal Cancer trials