Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To increase the efficacy of neoadjuvant PD-1/PD-1 checkpoint inhibitor in local advanced rectal cancer (LARC), we propose preoperative arterial infusion of Tirellizumab and oxaliplatin followed by tumor artery embolization with concurrent chemoradiotherapy as neoadjuvant regimen for LARC.
Based our previous multi-center randomized controlled study (Preoperative arterial perfusion Chemo- embolization combined with radiotherapy for locally advanced rectal cancer, NCT03601156), the idea of "preoperative arterial chemo-immuno-embolization combined with radiotherapy for locally advanced rectal cancer (CIETAI-R)" was proposed. This is also the serial study of CIETAI that explore the efficacy of tumor arterial chemo-immuno-embolization in lung cancer, LARC, metastatic liver cancer.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| local advanced rectal cancer | Experimental | local advanced rectal cancer are defined as T3/4NanyM0 or T1-2N+M0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIETAI-R | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response (pCR) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival (DFS) | 2 years | |
| overall survival (OS) | 3 years |
Not provided
Inclusion Criteria:
(Hematology and blood biochemistry examination must be completed within 7 days before the registration date) i) White blood cell count ≥ 4,000/mm3. ii) Neutrophil count ≥ 1,500/mm3. iii) Hemoglobin ≥ 10 g/dL. iv) Platelet count ≥ 100,000/mm3. v) Total bilirubin ≤ 1.5 times the upper limit of normal (ULN). vi. Liver function Index (AST & ALT) ≤ 1.5 times the upper limit of normal (ULN).
vii. Serum creatinine ≤1.5 times the upper limit of normal or creatinine clearance ≥60 ml/min.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daping Hospital, Third Military Medical University | Recruiting | Chongqing | Chongqing Municipality | 400042 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39405605 | Derived | Yang W, Qian C, Luo J, Chen C, Feng Y, Dai N, Li X, Xiao H, Yang Y, Li M, Li C, Wang D. First in human intraarterial delivery of tislelizumab for the treatment of pMMR locally advanced rectal cancer: A single-arm, open label, phase II clinical trial. Transl Oncol. 2024 Dec;50:102154. doi: 10.1016/j.tranon.2024.102154. Epub 2024 Oct 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |