对于局部复发性直肠癌(LRRC)患者,对放化疗的反应率为40%-50%。此外,只有大约40%-50%的复发性直肠癌患者能够接受R0切除.局部晚期直肠癌(LARC)的最新研究显示,将免疫治疗(PD-1/PD-L1抗体)与新辅助放化疗(nCRT)结合使用时,具有良好的协同作用。因此,将免疫治疗纳入LRRC患者的治疗方案有可能进一步改善缓解率和预后.为了调查这一点,进行了TORCH-R试验.这个未来,单臂,两个队列,II期试验侧重于使用大分割放疗,化疗,和无或有寡转移的LRRC患者的免疫治疗。该试验将包括两个队列:队列A包括因局部复发而未接受治疗的直肠癌患者,队列B包括一线化疗后疾病进展的患者。队列A和队列B患者将接受25-40Gy/5Fx照射或15-30Gy/5Fx再照射治疗盆腔复发,分别。随后,他们将接受18周的化疗,托里帕利玛,和立体定向消融放疗(SABR)在化学免疫治疗周期之间的所有转移性病变。关于完全反应(CR)随访的决定,根治性手术,非切除的持续治疗,或退出试验由多学科小组(MDT)完成.这项研究的主要终点是局部客观反应率(ORR)。次要终点包括肾外反应率,响应的持续时间,局部复发R0切除率,无进展生存期(PFS),总生存期(OS),安全性和耐受性。值得注意的是,这项试验代表了诱导大分割放疗的首次临床探索,化疗,和LRRC患者的免疫治疗。
■https://clinicaltrials.gov/study/NCT05628038,标识符NCT05628038。
For patients with locally recurrent rectal cancer (LRRC), the response rate to chemoradiotherapy is 40%-50%. Additionally, only approximately 40%-50% of patients with recurrent rectal cancer are able to undergo R0 resection. Recent studies in locally advanced rectal cancer (LARC) have shown promising synergistic effects when combining immunotherapy (PD-1/PD-L1 antibodies) with neoadjuvant chemoradiotherapy (nCRT). Therefore, incorporating immunotherapy into the treatment regimen for LRRC patients has the potential to further improve response rates and prognosis. To investigate this, the TORCH-R trial was conducted. This prospective, single-arm, two-cohort, phase II trial focuses on the use of hypofractionated radiotherapy, chemotherapy, and immunotherapy in LRRC patients without or with oligometastases. The trial will include two cohorts: cohort A consists of rectal cancer patients who are treatment-naive for local recurrence, and cohort B includes patients with progressive disease after first-line chemotherapy. Cohort A and cohort B patients will receive 25-40 Gy/5 Fx irradiation or 15-30 Gy/5 Fx reirradiation for pelvic recurrence, respectively. Subsequently, they will undergo 18 weeks of chemotherapy, toripalimab, and stereotactic ablative radiotherapy (
SABR) for all metastatic lesions between chemoimmunotherapy cycles. Decisions regarding follow-up of complete response (CR), radical surgery, sustained treatment of non-resection, or exiting the trial are made by a multidisciplinary team (MDT). The primary endpoint of this study is the local objective response rate (ORR). The secondary endpoints include the extrapelvic response rate, duration of response, local recurrence R0 resection rate, progression-free survival (PFS), overall survival (OS), and safety and tolerability. Notably, this trial represents the first clinical exploration of inducing hypofractionated radiotherapy, chemotherapy, and immunotherapy in LRRC patients.
UNASSIGNED: https://clinicaltrials.gov/study/NCT05628038, identifier NCT05628038.