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This is a prospective, open-labelled study to evaluate the efficacy and safety of sequetial transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of initial unresectable colorectal cancer. The progression-free-survival (PFS) will be evaluated as the primary endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | sequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy |
|
| Control group | Active Comparator | neoadjuvant chemotherapy alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE protocol | Drug | Transarterial infusion chemotherapy: Oxaliplatin(85mg/m^2)+Raltitrexed(3mg) Chemoembolization: Lipiodol emulsion (lipiodol 10ml+ Oxaliplatin 85mg +Lidocaine 1ml),The endpoint for embolization was defined as stagnation of blood flow of the posterior mesenteric artery. Intervention cycle:4W; Treatment times: 2. followed by mFOLFOX6 |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | ORR is defined as the percentages of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria | up to 3 years |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Wu, M.D. | Contact | +86 13938570175 | wuganghenan2015@163.com |
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|
| Neoadjuvant Chemotherapy | Drug | mFOLFOX6, Q2W |
|
The time from recruitment to death due to any cause.
| up to 3 years |
| Pathological response rate (PCR+MPR) | Pathologic complete response (pCR) was defined as absence of viable tumor in the post-treatment surgical specimens and major pathologic response (MPR) was defined as ≤ 10% viable tumor. | up to 3 years |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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