Clinical Trial Finder

Comments

Trial in Italy, for only metastatic CRC patients who achieved NED (no evidence of disease) after completion of any treatments for stage IV CRC, no more than 10 weeks before.

Patients will be randomized to receive standard of care ( just observation follow-up) or a combination of low dose of regorafenib (Stivarga, oral) and durvalumab (Imfinzi, intravenous; immunotherapy, anti PD-L1)

Crossover from the SOC to the experimental arm is allowed in case of relapse.

Contacts

Inclusion Criteria

Inclusion Criteria:

≥ 18 years; ECOG PS 0-1;
Body weight >30 kg;
Histologically confirmed diagnosis of colorectal adenocarcinoma;
Patients must be in NED after completion of any treatments for stage IV CRC, including resections, RFA; RT with or without neoadjuvant/adjuvant therapies or CR after chemotherapy;
Patients must be randomized within 10 weeks since the achievement of the NED state. Those who have also received adjuvant therapy following the locoregional treatment are still eligible, provided they are randomized within 4 weeks since the last chemotherapy cycle;
NED state ascertained by means of CT scan and/or PET scan and/or MRI scan;
Life expectancy of at least 12 weeks;
CEA within normal limits;
No residual toxicity from previous chemotherapy;
Adequate organ function;

Exclusion Criteria

Exclusion criteria:

MSI/dMMR patients;
Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia and vitiligo;
Active or prior documented autoimmune or inflammatory disorders;
Relevant concomitant comorbidities;