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Following systemic therapy in metastatic colorectal cancer(mCRC),RAS (including KRAS, NRAS and HRAS gene) status may change from a mutant(MT) to a wild-type(WT),a phenomenon known as "NeoRAS WT"mCRC.NeoRAS WT can be detected by longitudinal circulating tumor DNA(ctDNA) analysis.Therefore, this prospective phase II Study was design to explore the detection rate of peripheral blood ctDNA testing for NeoRAS WT and its guiding value for subsequent treatment for mCRC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAS mutated metastatic colorectal cancer | Experimental | RAS mutated metastatic colorectal cancer were routinely treated after enrollment. When the disease progression was confirmed by imaging, peripheral blood ctDNA detection was performed to observe whether they were transformed into NeoRAS wild-type patients. If NeoRAS wild- type was detected, the anti-EGFR therapy may be considered as the following therapy for patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug | Cetuximab is given In patients with NeoRAS WT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate of NeoRAS WT | Proportion of occurrence of neoRAS WT | up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) of NeoRAS wild-type patients receiving anti-EGFR therapy | Objective response rate of NeoRAS wild-type patients receiving anti-EGFR (epidermal growth factor receptor) therapy | Follow-up was conducted for 2 years after enrollment |
| Progression-free survival (PFS) in NeoRAS WT patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junjie Peng, PhD | Contact | +86 13917373312 | pengjj@shca.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Junjie Peng, PhD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33538338 | Background | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. | |
| 37364334 | Background | Osumi H, Takashima A, Ooki A, Yoshinari Y, Wakatsuki T, Hirano H, Nakayama I, Okita N, Sawada R, Ouchi K, Fukuda K, Fukuoka S, Ogura M, Takahari D, Chin K, Shoji H, Kato K, Ishizuka N, Boku N, Yamaguchi K, Shinozaki E. A multi-institutional observational study evaluating the incidence and the clinicopathological characteristics of NeoRAS wild-type metastatic colorectal cancer. Transl Oncol. 2023 Sep;35:101718. doi: 10.1016/j.tranon.2023.101718. Epub 2023 Jun 24. |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Progression-free survival (PFS) : time from enrollment to disease progression from any cause |
| Follow-up was conducted for 2 years after enrollment |
| Overall survival (OS) in NeoRAS WT patients | Overall survival (OS) : time from enrollment to death from any cause, loss of participants, and time of last follow-up | Follow-up was conducted for 2 years after enrollment |
| 37064137 | Background | Nicolazzo C, Magri V, Marino L, Belardinilli F, Di Nicolantonio F, De Renzi G, Caponnetto S, De Meo M, Giannini G, Santini D, Cortesi E, Gazzaniga P. Genomic landscape and survival analysis of ctDNA "neo-RAS wild-type" patients with originally RAS mutant metastatic colorectal cancer. Front Oncol. 2023 Mar 29;13:1160673. doi: 10.3389/fonc.2023.1160673. eCollection 2023. |
| 34153718 | Background | Osumi H, Vecchione L, Keilholz U, Vollbrecht C, Alig AHS, von Einem JC, Stahler A, Striefler JK, Kurreck A, Kind A, Modest DP, Stintzing S, Jelas I. NeoRAS wild-type in metastatic colorectal cancer: Myth or truth?-Case series and review of the literature. Eur J Cancer. 2021 Aug;153:86-95. doi: 10.1016/j.ejca.2021.05.010. Epub 2021 Jun 18. |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |