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It's not possible to complete in our hospital.
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Objective: To compare the outcome of patients with colorectal cancer who treated with adjuvant therapy or Apatinib with adjuvant therapy postoperatively.
Language: English.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib group | Experimental | Apatinib combined with CAPEOX program. Apatinib tablets: 500 mg po qd from the second cycle of chemotherapy. Oxaliplatin: Day 1, 130mg/m2, IV infusion. Capecitabine: Day 1-14, 1000mg/m2 Twice Daily, po. A total of 6 cycles, 3 weeks apart of chemotherapy. |
|
| Control group | Placebo Comparator | CAPEOX program. Oxaliplatin: Day 1, 130mg/m2, IV infusion. Capecitabine: Day 1-14, 1000mg/m2 Twice Daily, po. A total of 6 cycles, 3 weeks apart of chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib combine with CAPEOX adjuvant chemotherapy for resectable colorectal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants recurrence-free survival | Number of Participants recurrence-free survival in intervention group and control group. | 1 year |
| Number of Participants overall survival | Number of Participants overall survival in intervention group and control group. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants recurrence-free survival | Number of Participants recurrence-free survival in intervention group and control group. | 2 years |
| Number of Participants overall survival | Number of Participants overall survival in intervention group and control group. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants recurrence-free survival | Number of Participants recurrence-free survival in intervention group and control group. | 3 years |
| Number of Participants overall survival | Number of Participants overall survival in intervention group and control group. |
Inclusion Criteria:
ECOG performance status score: 0-1.
All colorectal cancer patients underwent curative intent surgery
Patients in stage â…¡(Any T, N0, M0) with multiple high-risk factors or stage â…¢ (any T, N1-2, M0) which confirmed by pathology.
Patients who did not receive other treatments for colorectal adenocarcinoma after surgery;
The main organ function is good, patients must meet the following requirements with 14 days before using Apatinib:
blood routine examination:
biochemical examination:
Cardiac Doppler Ultrasonography: Left ventricular ejection fraction (LVEF) ≥ 50%.
The surgical incision has been healed, and no bleeding tendency;
Sign informed consent;
Compliance is good, family members agreed to accept survival follow-up.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yunhong Tian | Nanchong Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yunhong Tian | Nanchong | Sichuan | 637000 | China |
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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 |
|---|---|
| C553458 | apatinib |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| CAPEOX | Drug | CAPEOX adjuvant chemotherapy for resectable colorectal |
|
|
| 2 years |
| 3 years |
| Number of Participants recurrence-free survival | Number of Participants recurrence-free survival in intervention group and control group. | 4 years |
| Number of Participants overall survival | Number of Participants overall survival in intervention group and control group. | 4 years |
| Number of Participants recurrence-free survival | Number of Participants recurrence-free survival in intervention group and control group. | 5 years |
| Number of Participants overall survival | Number of Participants overall survival in intervention group and control group. | 5 years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |