The primary aim of phase II CEIL study is to evaluate the efficacy of cetuximab and envafolimab plus mFOLFOXIRI versus cetuximab plus mFOLFOX6 as first line treatment of patients with initially unresectable and previously untreated RAS/BRAF wild-type, MSS, left-side metastatic colorectal cancer(mCRC), in terms of Progression-free Survival.
This is a prospective, open-label, multi-center, randomized controlled phase II trial in which patients with initially unresectable and previously untreated RAS/BRAF wild-type, MSS, left-side mCRC will be randomized to two therapy groups: Experimental arm A: receive induction treatment with cetuximab and envafolimab plus mFOLFOXIRI up to 8 cycles followed by maintenance with cetuximab and envafolimab plus 5-FU/LV until disease progression, unacceptable toxicity or patient's refusal. Standard arm B: receive induction treatment with cetuximab plus mFOLFOX6 up to 8 cycles followed by maintenance with cetuximab plus 5-FU/LV until disease progression, unacceptable toxicity or patient's refusal. The second- and subsequent lines of treatment will be at investigators' choice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
198
Cetuximab 500mg/m² + envafolimab 200mg + irinotecan 150 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle up to max 8 cycles, followed by maintenance with cetuximab 500mg/m² + envafolimab 200mg + leucovorin 200 mg/m² + 5-FU 400 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle until PD, unacceptable toxicity or patient's refusal.
Cetuximab 500mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 400 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle up to max 8 cycles, followed by maintenance with cetuximab 500mg/m² + leucovorin 200 mg/m² + 5-FU 400 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle until PD, unacceptable toxicity or patient's refusal.
The First People's Hospital of Foshan
Foshan, Guangdong, China
RECRUITINGThe Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGAffiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
RECRUITINGProgression free survival
Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Time frame: 2 year
Objective response rate
CR + PR rate according to RECIST
Time frame: 2 year
Disease control rate
CR + PR + SD rate according to RECIST
Time frame: 2 year
No evidence of disease
The percentage of patients who had a curative treatment following protocol treatment, i.e., liver metastases that can be completely resected and/or ablated with no evidence of residual malignant disease.
Time frame: 2 year
Overall survival
Time from date of randomization until the date of first documented death from any cause.
Time frame: 4 year
Safety (Incidence of Adverse Events)
Percentage of patients, relative to the total of enrolled subjects, experiencing a specific adverse event of grade 3/4, according to National Cancer Institute Common Toxicity Criteria (version 5.0), during the induction and the maintenance phases of treatment.
Time frame: 2 year
Health related quality of life
Scores according to EORTC QLQ-CR29 scoring manual.
Time frame: Every 2 weeks after the first treatment until 6 months.
Quality-adjusted time without symptoms or toxicity
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Q-TWiST was calculated as the sum of the utility-weighted mean durations for each health state. Q-TWiST = (TWiST × μTWiST) + (TOX × μTOX) + (REL × μREL). Base case utilities: μTWiST = 1, μTOX = 0.5, μREL = 0.5. Duration of AEs was measured until disease progression. All time in TOX was front-loaded at the beginning of threrapy.
Time frame: 2 year