A Study of Cetuximabβ Combined With Envolimab and mFOLFOX6 in Subjects With Advanced Colorectal Cancer

ConditionAdvanced Colorectal Cancer

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorTao Zhang

About this trial

A study of Cetuximabβ combined with Envolimab and mFOLFOX6 in Subjects with Advanced Colorectal Cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

have agreed and signed an informed consent form (ICF) and are willing and able to comply with planned visits, study treatments, laboratory tests and other experimental procedures.

At the time of signing the ICF, patients must be ≥18 years of age and have a life expectancy of ≥12 weeks in either males or females.

Histologically or cytologically confirmed RAS and BRAF wild-type, MSS type colorectal adenocarcinoma.

Advanced or metastatic colorectal cancer (AJCC/UICC stage IV) clearly defined by imaging, with at least one measurable lesion that meets the requirements of the criteria for evaluating the efficacy of solid tumors (RECIST version 1.1).

Disqualifiers

previous or concurrent other active malignancies (except for malignancies that have been curatively treated and have been free of morbidity for more than 5 years or carcinoma in situ that can be cured by adequate treatment).

Current gastrointestinal diseases such as duodenal ulcer, ulcerative colitis, intestinal obstruction, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator.

Thrombotic or embolic events such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, deep vein thrombosis within 12 months prior to enrollment in the study.

Myocardial infarction, severe/unstable angina pectoris, NYHA class 2 or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure within 12 months prior to study entry.

Trial design

Design model

Single group

Treatments tested in this trial

Cetuximabβ combined with Envolimab and mFOLFOX6
Drug
Envolimab, 200 mg, sc, day 1; Cetuximabβ 500 mg/m2 IV over 60- 120 min, day 1; chemotherapy mFOLFOX6; with the above regimen every 14 days for 1 treatment cycle. Then patients who did not experience disease progression within 8-12 cycles were entered into maintenance therapy, which consisted of a fluorouracil-based-chemotherapy with Cetuximabβ and Envolimab regimen until progression or unacceptable toxicity.

Treatment groups

42 Participants

are divided into 1 treatment group

Group A: experimental groupExperimental treatment 1 intervention

Trial outcomes