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The goal of this clinical trial is to evaluating the efficacy and safety of radiotherapy combined with Tislelizumab, Liposomal Irinotecan, and Capecitabine in patients with locally advanced mid-lower rectal cancer with pMMR.. Patients would be included as:1. Aged between 18-75 years, with no gender restrictions; 2. Biopsy pathology confirmed as pMMR type locally advanced mid-lower rectal adenocarcinoma (tumor lower margin ≤ 10 cm from the anal verge); 3.With the following high-risk factors: T3N+/T4/N2/EMVI+/MRF+/lateral lymph node metastasis/inability to preserve anal function during surgery; 4. No distant metastasis observed in routine chest and abdominal CT scans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Irinotecan | Experimental | Treatment regimen:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Irinotecan | Drug | In this study, the novel drug liposomal irinotecan was added, replacing the conventional formulation of irinotecan, and used as an intensified chemotherapy regimen (liposomal irinotecan + capecitabine) combined with immunotherapy and radiotherapy for neoadjuvant treatment of mid-lower rectal cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate | Complete Remission Rate (CRR) refers to the percentage of patients who have achieved complete remission (CR) after treatment, typically in the context of cancer therapy. Complete remission means that all signs of cancer have disappeared, as determined by clinical, radiological, or pathological evaluation. However, this does not necessarily imply that the disease is cured, as microscopic cancer cells may still be present in the body and the patient may be at risk of relapse. CRR is an important measure used to assess the effectiveness of a treatment regimen, especially in clinical trials and cancer treatment protocols.The complete remission rate includes both pathological complete remission rate and clinical complete remission rate. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathological Remission Rate | Major Pathological Remission Rate (MPRR) refers to the percentage of patients who achieve a significant reduction or near-total absence of tumor cells in pathological examination after receiving treatment. The threshold for defining "major" refers to a large proportion (e.g., ≥ 90%) of the tumor being eliminated or showing no viable malignant cells in the pathology report. |
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Here is the updated format for the **Eligibility Criteria** with bullet points for each item:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiarui Lin | Contact | 86-13794112671 | zljr@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shantou University Medical College Cancer Hospital | Recruiting | Shantou | Guangdong | 515000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31789476 | Background | Bang YJ, Li CP, Lee KH, Chiu CF, Park JO, Shan YS, Kim JS, Chen JS, Shim HJ, Rau KM, Choi HJ, Oh DY, Belanger B, Chen LT. Liposomal irinotecan in metastatic pancreatic adenocarcinoma in Asian patients: Subgroup analysis of the NAPOLI-1 study. Cancer Sci. 2020 Feb;111(2):513-527. doi: 10.1111/cas.14264. Epub 2019 Dec 20. | |
| 26615328 |
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| 24 months |
| Wang-Gillam A, Li CP, Bodoky G, Dean A, Shan YS, Jameson G, Macarulla T, Lee KH, Cunningham D, Blanc JF, Hubner RA, Chiu CF, Schwartsmann G, Siveke JT, Braiteh F, Moyo V, Belanger B, Dhindsa N, Bayever E, Von Hoff DD, Chen LT; NAPOLI-1 Study Group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29. |
| 33119477 | Background | Zhu J, Liu A, Sun X, Liu L, Zhu Y, Zhang T, Jia J, Tan S, Wu J, Wang X, Zhou J, Yang J, Zhang C, Zhang H, Zhao Y, Cai G, Zhang W, Xia F, Wan J, Zhang H, Shen L, Cai S, Zhang Z. Multicenter, Randomized, Phase III Trial of Neoadjuvant Chemoradiation With Capecitabine and Irinotecan Guided by UGT1A1 Status in Patients With Locally Advanced Rectal Cancer. J Clin Oncol. 2020 Dec 20;38(36):4231-4239. doi: 10.1200/JCO.20.01932. Epub 2020 Oct 29. |
| 38462629 | Background | Yang Z, Gao J, Zheng J, Han J, Li A, Liu G, Sun Y, Zhang J, Chen G, Xu R, Zhang X, Liu Y, Bai Z, Deng W, He W, Yao H, Zhang Z. Efficacy and safety of PD-1 blockade plus long-course chemoradiotherapy in locally advanced rectal cancer (NECTAR): a multi-center phase 2 study. Signal Transduct Target Ther. 2024 Mar 11;9(1):56. doi: 10.1038/s41392-024-01762-y. |
| 34196693 | Background | Rahma OE, Yothers G, Hong TS, Russell MM, You YN, Parker W, Jacobs SA, Colangelo LH, Lucas PC, Gollub MJ, Hall WA, Kachnic LA, Vijayvergia N, O'Rourke MA, Faller BA, Valicenti RK, Schefter TE, George S, Kainthla R, Stella PJ, Sigurdson E, Wolmark N, George TJ. Use of Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: Initial Results From the Pembrolizumab Arm of a Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 Aug 1;7(8):1225-1230. doi: 10.1001/jamaoncol.2021.1683. |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C584112 | irinotecan sucrosofate |
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