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This clinical trial aims to evaluate the efficacy, safety of FOLFIRI with vemurafenib and cetuximab in Advanced Colorectal Cancer Patients with BRAF V600E mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FIVC group | Experimental | Irinotecan 180mg/m2 iv gtt (14 days per course) leucovorin 400mg/m2 iv gtt (14 days per course) 5-fluorouracil 400mg/m2 iv (14 days per course) 5-fluorouracil 2400 mg/m2 46h (14 days per course) vemurafenib 960mg po bid cetuximab 500mg/m2 iv gtt (14 days per course) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vemurafenib | Drug | 960mg po bid |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | Evaluation of tumor burden based on RECIST criteria every 3 cycles(each cycle is 14 days), ORR is the proportion of patients with reduction in tumor burden of a predefined amount, including complete response and partial response. | up to 55 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | Evaluation of tumor burden based on RECIST criteria every 3 cycles(each cycle is 14 days), and DCR is the proportion of patients with reduction in tumor burden of a predefined amount, including complete response, partial response and stable disease | up to 55 months |
| Progression-free survival |
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Inclusion Criteria:
Exclusion Criteria:
Patients with KRAS/NRAS mutation;
Patients with major surgery or severe trauma within 4 weeks before the first medication;
Patients with hypersensitivity to the components in the study protocol;ï¼›
Patients who are ready to give birth or are pregnant.。
Patients with brain metastases 。
Bone marrow, liver and kidney function did not meet the requirements of chemotherapy as follows:
Patients with cancers other than advanced colorectal cancer within five years prior to the start of treatment in this study. Cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor were excluded;ï¼›
Patients without legal capacity or limited civil capacity;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan-Sheng Zang, Prof | Contact | +8613816584620 | doctorzangys@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhan Wang, Prof | Shanghai Changzheng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changzheng Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35074651 | Derived | Wang Z, Qin BD, Ye CY, Wang MM, Yuan LY, Dai WP, Sun L, Liu K, Qin WX, Jiao XD, Li XN, Zang YS. Cetuximab and vemurafenib plus FOLFIRI (5-fluorouracil/leucovorin/irinotecan) for BRAF V600E-mutated advanced colorectal cancer (IMPROVEMENT): An open-label, single-arm, phase II trial. Eur J Cancer. 2022 Mar;163:152-162. doi: 10.1016/j.ejca.2021.12.028. Epub 2022 Jan 21. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077484 | Vemurafenib |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Cetuximab | Drug | 500mg/m2 iv gtt (14 days per course) |
|
|
Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 6 weeks |
| Time from treatment beginning until the date of first documented progression, assessed up to 55 months |
| Overall survival | From date of treatment beginning until the date of death from any cause, through study completion, an average of 6 weeks | Time from treatment beginning until date of death from any cause, assessed up to 55 months |
| adverse events | Incidence of Treatment-related adverse Events | Through study completion, an average of 4 weeks |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| Sulfur Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |