Adjuvant Chemoradiation and Immunotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Cancer: A Randomized Clinical Trial.

However, effective adjuvant treatments specifically for patients with resectable EHC and GBC are scarce.

然而，针对可切除EHC和GBC患者的有效辅助治疗方案却很少。

Background

To evaluate the safety and efficacy of immunotherapy combining with chemoradiotherapy.

评估免疫治疗联合放化疗的安全性和有效性。

DESIGN, SETTING, AND PARTICIPANTS: In the ACCORD randomized clinical trial, from April 2020 to June 2022, patients with EHC and GBC after curative resection were assessed for eligibility.

设计、环境和参与者：在ACCORD随机临床试验中，从2020年4月到2022年6月，对接受治愈性切除术后的EHC和GBC患者进行了资格评估。

Patients were randomized 1:1 into to the combination camrelizumab plus concurrent capecitabine and radiotherapy group or the observation group.

患者被随机分为1:1，一组接受卡瑞利珠单抗联合同步卡培他滨和放疗，另一组为观察组。

Data were analyzed from June to August 2024.

数据分析时间为2024年6月至8月。

Methods

The intervention group received camrelizumab every 3 weeks after surgery.

干预组在手术后每3周接受卡瑞利珠单抗治疗。

After 2 courses of camrelizumab treatment, patients received capecitabine with concurrent radiotherapy.

经过2个疗程的卡瑞利珠单抗治疗后，患者接受卡培他滨联合同步放疗。

Patients in the observation group received no anticancer treatment unless relapse was detected.

观察组的患者除非检测到复发，否则不接受抗癌治疗。

main_outcomes_and_measures

The primary end point was overall survival(OS) and the secondary end points included recurrence-free survival (RFS) and safety.

主要终点是总生存（OS），次要终点包括无复发生存（RFS）和安全性。

Results

Of 93 included patients, 48 (52%) were female, and the median (range) age was 62 (31-70) years.

在纳入的93名患者中，48名（52%）为女性，中位年龄为62岁（范围31-70岁）。

Patients' baseline characteristics were comparable in the 2 groups.

两组患者的基线特征具有可比性。

With a median (IQR) follow up of 36 (32-39) months, patients in the combination treatment group significantly better OS and RFS.

在中位随访时间（四分位数间距）为36（32-39）个月的情况下，联合治疗组患者的总生存期（OS）和无复发生存期（RFS）显著优于对照组。

The 1-year, 2-year and 3-year OS rates were 95.7% (95% CI, 83.7-98.9), 71.4% (95% CI, 56.4-82.5), and 58.2% (95% CI, 40.4-72.4), respectively, in the combination treatment group and 80.9% (95% CI, 66.4-89.5), 52.9% (95% CI, 37.7-65.9), and 30.5% (95% CI, 16.5-45.7), respectively, in the observation group (hazard ratio, 0.43; 95% CI, 0.24-0.79; P = .004).

联合治疗组的1年、2年和3年总生存率分别为95.7%（95%置信区间，83.7-98.9）、71.4%（95%置信区间，56.4-82.5）和58.2%（95%置信区间，40.4-72.4），而观察组则分别为80.9%（95%置信区间，66.4-89.5）、52.9%（95%置信区间，37.7-65.9）和30.5%（95%置信区间，16.5-45.7），联合治疗组的危险比为0.43（95%置信区间，0.24-0.79；P = .004）。

The 1-year, 2-year and 3-year RFS rates were 78.3% (95% CI, 63.4-87.7), 54.0% (95% CI, 38.6-67.1), and 40.3% (95% CI, 25.3-54.8), respectively, in the combination treatment group and 55.3% (95% CI, 40.1-68.1), 27.0% (95% CI, 15.2-40.3), and 17.2% (95% CI, 7.7-29.8), respectively, in the observation group (hazard ratio, 0.46; 95% CI, 0.28-0.76; P < .001).

在联合治疗组中，1年、2年和3年的无复发生存（RFS）率分别为78.3%（95% CI，63.4-87.7）、54.0%（95% CI，38.6-67.1）和40.3%（95% CI，25.3-54.8），而在观察组中分别为55.3%（95% CI，40.1-68.1）、27.0%（95% CI，15.2-40.3）和17.2%（95% CI，7.7-29.8）（风险比，0.46；95% CI，0.28-0.76；P < .001）。

In the combination treatment group, only 6 patients (13%) experienced treatment delay for camrelizumab, and all patients completed the chemoradiation treatment, with no treatment-related deaths.

在联合治疗组中，只有6名患者（13%）因卡瑞利珠单抗治疗出现了延迟，所有患者均完成了化疗和放疗治疗，且没有治疗相关的死亡事件。

conclusions_and_relevance

In this randomized clinical trial, camrelizumab plus concurrent capecitabine and radiotherapy as an adjuvant therapy demonstrated superior survival outcomes over observation in patients with resectable EHC/GBC with a well-tolerable safety profile.

在这项随机临床试验中，卡瑞利珠单抗联合同步卡培他滨和放疗作为辅助治疗，在可切除的肝外胆管癌/胆囊癌患者中显示出优于单纯观察的生存结果，并具有良好的耐受性安全特性。

The observed camrelizumab plus concurrent capecitabine and radiotherapy efficacy warrants further study with active treatment (chemotherapy or chemoradiation therapy) as the control group.

观察到的卡瑞利珠单抗联合同步卡培他滨和放疗的疗效值得进一步研究，以积极治疗（化疗或放化疗）作为对照组。

trial_registration

ClinicalTrials.gov Identifier: NCT04333927.

临床试验注册号：NCT04333927。