The Efficacy and Safety of Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil (TAS-102) for Total Neoadjuvant Therapy of Microsatellite Stable (MSS) Locally Advanced Low Rectal Adenocarcinoma: an Prospective, Single Arm Clinical Trial （SCRIPBOT Trial）

A Prospective Single-Arm Study of Short-Course Radiotherapy Followed by PD-1 Monoclonal Antibody, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil for Total Neoadjuvant Therapy in MSS Locally Advanced Low Rectal Cancer. This is a Non-Randomized, Single Group Assignment, Open Label, Phase: Phase II study. The Primary Objective is to assess the organ preservation rate (clinical complete response, cCR) after total neoadjuvant therapy. Secondary Objectives are Tumor regression grade (TRG), 3-year overall survival (OS) and disease-free survival (DFS), and Safety and quality of life (QoL). In this study, the investigators will perform the multi-dimensional omics study to explore the tumors microenvironments, explore the characteristics of the treatment benefit population, and try to construct an efficacy prediction model to screen the treatment benefit population early and implement precise treatment.

Start Date01 Apr 2025

Sponsor / Collaborator

Sir Run Run Shaw Hospital

NCT06843434

/ RecruitingPhase 2IIT

A Phase II Study of Neoadjuvant Botensilimab and Balstilimab Immunotherapy for Mismatch Repair Proficient Rectal Adenocarcinoma

The purpose of this study is to find out whether the combination of botensilimab and balstilimab (BOT/BAL) is a safe and effective treatment that causes few or mild side effects for people with mismatch repair proficient (MMRp)/microsatellite stable (MSS) locally advanced rectal adenocarcinoma. The investigators will also find out whether BOT/BAL is an effective treatment when given in combination with standard chemotherapy.

Start Date20 Feb 2025

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+1]

NCT06281405

/ Not yet recruitingPhase 2IIT

A Prospective Randomized Phase II Trial of CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for Microsatellite Stable Locally Advanced Rectal Cancer (TORCH-iTNT)

TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives SCRT (25Gy/5Fx) followed by 6 cycles of ToriCAPOX. TME surgery is scheduled after TNT while a watch and wait (W&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response [pCR] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.

Start Date01 Mar 2024

Sponsor / Collaborator

Fudan University

100 Clinical Results associated with Microsatellite Stable Rectal Carcinoma

100 Translational Medicine associated with Microsatellite Stable Rectal Carcinoma

0 Patents (Medical) associated with Microsatellite Stable Rectal Carcinoma

Literatures (Medical) associated with Microsatellite Stable Rectal Carcinoma

25 Apr 2024·Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery

[Neoadjuvant strategy for locally advanced colorectal cancer based organ preservation].

Review

Author: Hu, H B ; Deng, Y H ; Zhang, J W ; Wu, Z H ; Cheng, Y

Neoadjuvant therapy for locally advanced colorectal cancer has made great progress in the past 20 years, but there are still limitations such as side effects, organ dysfunction and unsatisfactory control of metastasis. In recent years, with the improvement of surgical techniques and further development of molecular research, how to further improve local control, reduce distant metastasis, and even avoid surgery according to clinical remission to achieve organ preservation, is the current demand and research goal. With the advancement of molecular research, colorectal cancer has different treatment strategies based on microsatellite status. For patients with microsatellite instability locally advanced colorectal cancer, immune checkpoint inhibitor therapy significantly increased the pathologic complete response rate, reduced the incidence of adverse events and improved organ function compared with conventional chemoradiotherapy. For patients with microsatellite stable locally advanced colon cancer, neoadjuvant therapy is still in the exploratory stage. The standard of care is surgery combined with perioperative chemotherapy. For microsatellite stable locally advanced rectal cancer, the complete response rate is improved by enhancing neoadjuvant therapy, which helps to preserve organs. On the other hand, selective radiotherapy preserves organ function and improves quality of life. This article reviews the neoadjuvant treatment strategies for locally advanced colorectal cancer based on organ-sparing strategies.

13 Sep 2023·BMJ open

Neoadjuvant chemoradiation therapy combined with immunotherapy for microsatellite stable ultra-low rectal cancer (CHOICE II): study protocol of a multicentre prospective randomised clinical trial.

Article

Author: Gao, Xianhua ; Peng, Zhiying ; Jia, Hang ; Gong, Haifeng ; Yu, Guanyu ; Wen, Rongbo ; Zhang, Wei ; Yu, Yue ; Lou, Zheng ; Zhang, Tianshuai ; Fan, Hao ; Zhou, Leqi ; Pan, Anfu ; Zhu, Xiaoming

INTRODUCTIONNeoadjuvant chemoradiotherapy (nCRT) could bring tumour shrinking and downstaging and increase the probability of organ preservation for patients with low rectal cancer. But for ultra-low rectal cancer, there is little possibility for organ preservation. Immunotherapy has been shown to have significant survival benefits in microsatellite instability-high patients but poor response in microsatellite stable (MSS) patients. Studies have demonstrated that radiotherapy and immunotherapy have synergistic effects in cancer treatment. There is no existing evidence about the clinical efficacy of immunotherapy combined with nCRT for patients with MSS ultra-low rectal cancer.METHOD AND ANALYSISThis trial is an open-labelled multicentre prospective randomised controlled trial (NCT05215379) with two parallel groups and allocation ratio 1:1 (nCRT+immunotherapy vs nCRT group). Eligible participants will be aged 18-75 years, with a desire for anus preservation, confirmed cT_1-3aN_0-1M₀ rectal adenocarcinoma, confirmed MSS type, inferior margin of ≤5 cm from the anal verge. The primary endpoint of this trial is complete clinical response (cCR) rate. Immunotherapy is added after 1 week of chemoradiotherapy for two cycles, and then the patients will be administered two cycles of immunotherapy and CAPOX. The evaluations will be carried out after the completion of the whole neoadjuvant therapy. We expect the programme to improve the cCR rate and the quality of life for patients with ultra-low rectal cancer.ETHICS AND DISSEMINATIONThis trial was approved by the Ethics committee of Changhai Hospital and other medical centres (Grant number:CHEC2022-118). The results of this study will provide further insight into the clinical efficacy of immunotherapy in combination with nCRT in patients with MSS ultra-low rectal cancer.TRIAL REGISTRATION NUMBERNCT05215379.

03 Apr 2023·Expert Review of Anticancer Therapy

Neutrophil-to-lymphocyte ratio predicts survival of patients with rectal cancer receiving neo-adjuvant chemoradiation followed by radical resection: a meta-analysis

Review

Author: Colloca, Giuseppe ; Venturino, Antonella ; Guarneri, Domenico

BACKGROUNDNeutrophil-to-lymphocyte ratio is suggested as a prognostic and predictive factor for patients with rectal cancer. The purpose of the current meta-analysis is to evaluate the relationship between neutrophil-lymphocyte ratio (NLR) and the outcome of patients, with rectal cancer receiving chemoradiation and surgery.METHODSA systematic review on two databases and a selection of studies were done. Thereafter, two meta-analyses were performed, evaluating the relationship of baseline NLR with overall survival (OS) and disease-free survival (DFS).RESULTSThirty-one retrospective studies were selected. Twenty-six studies have documented a significant relationship of NLR to OS (HR 2.05, CI 1.66-2.53), whereas 23 studies have reported a weaker but significant relationship of NLR to DFS (HR 1.78, CI 1.49-2.12). Among the moderator variables, a possible effect for age and sex on the relationship of NLR with DFS is suggested.CONCLUSIONSBaseline NLR >3 is a simple and reproducible prognostic factor, with a more consistent effect in the elderly. It could be a reliable variable to support clinicians in defining personalized treatment strategies, even though a standardization of the cutoff and a better characterization among microsatellite unstable rectal tumors are necessary.

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