To assess the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma (with symptomatic dysphagia or oligometastatic disease),and to evaluate the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma (without symptomatic dysphagia or oligometastatic disease).
The treatment of advanced second-line esophageal squamous cell carcinoma has always been mainly chemotherapy. Since 2019, a number of phase III clinical trials (ESCORT, KEYNOTE-181, RATIONALE 302, ATRACTION-3, etc.) have confirmed that there is a significant difference in OS between the immune monotherapy group and the chemotherapy group, and immunotherapy can bring better survival benefits. Although the above studies have brought new possibilities for second-line patients with advanced esophageal cancer, the results of the study show that the response rate of immune monotherapy is limited, with a single-agent ORR of about 13%-20%, mPFS of about 2 months, and mOS about 8 months. Therefore, finding a suitable combination therapy model to further improve the efficacy of advanced second-line esophageal cancer has gradually become a research hotspot in recent years. In recent years, many experts have also made a lot of explorations. The combination of anti-angiogenic drugs and immunotherapy drugs can be synergistic. Dysphagia is a major symptom in patients with esophageal cancer, leading to significant nutritional deficiencies, pain, and subsequent deterioration in quality of life. Management of dysphagia is a key goal of esophageal cancer treatment, along with the need to improve nutritional status and quality of life, which may have a positive impact on the overall prognosis of patients. Current treatment methods for dysphagia include esophageal dilation, endoluminal stenting, systemic chemotherapy, external beam radiotherapy (EBRT), brachytherapy, and concurrent chemoradiotherapy (CTRT). At present, there is no consensus on how to better manage this symptom with these treatment regimens, and more research is needed to continue to explore. To assess the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma (with symptomatic dysphagia or oligometastatic disease), and to evaluate the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma (without symptomatic dysphagia or oligometastatic disease).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Adebrelimab 1200mg,d1,q3w, until disease progression or unacceptable toxicity
Apatinib 250mg,d1-21,q3w, until disease progression or unacceptable toxicity
Nab-paclitaxel: 125mg/m2 intravenously, D1, D8, q3w, 4-6 cycles;Intravenous infusion of 100 mg, D1, qw is used at the same time as radiotherapy. Ilinotecan: 125mg/m2 intravenously, D1, D8, q3w, 4-6 cycles; Capecitabine, 625 mg/m2 orally, d1-14, q3w; continued until disease progression, intolerable toxicity, or withdrawal due to other reasons; when synchronized with radiotherapy, 625mg/m2, bid, oral, d1-5, qw.
Radiotherapy mode: IMRT for the primary lesion and SBRT for the metastasis; If the patient has symptoms of dysphagia, the radiation dose is 1.8 Gy×28 F or 2 Gy×25 F, d1-5 5 times a week; If oligometastatic lesions occur in the body: the radiation dose is 8 Gy×5F, d1-5; If oligometastatic lesions occur in the brain, the radiation dose is 7 Gy×5F, d1-5.
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Progression-free survival,PFS
Time from randomization to patient's tumor progression or death
Time frame: 9 months
Objective Response Rate,ORR
The proportion of patients whose tumor shrinks to a certain amount and remains for a certain period of time
Time frame: 1 year
Overall survival,OS
The time from the beginning of randomization to death due to any cause.
Time frame: 1 year
Duration of Response,DoR
The time from the first assessment of the tumor as CR or PR to the first assessment of PD (Progressive Disease) or death from any cause.
Time frame: 1 year
Disease control rate,DCR
The proportion of patients whose tumors have shrunk or stabilized and remain for a certain period of time (mainly for solid tumors), including cases of complete response (CR), partial response (PR) and stable disease (SD).
Time frame: 1 year
Time to response
Time from randomization to the achievement of the first objective response
Time frame: 1 year
1-year OS rate
Percentage of patients who are still alive after 1 year
Time frame: 1 year
9-month survival rate
Percentage of patients who are still alive after 9-month
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.