NCT06464614

Adebrelimab in Combination With Apatinib and Chemotherapy/Chemoradiotherapy in Immuno-experienced Second-line ESCC.

A Double-arm, Non-randomized Controlled, Open-label Clinical Study of Adebrelimab in Combination With Apatinib and Chemotherapy/Chemoradiotherapy in Immuno-experienced Second-line Esophageal Squamous Cell Carcinoma.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: The First Affiliated Hospital of Henan University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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).

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Adebrelimab	Adebrelimab 1200mg，d1，q3w, until disease progression or unacceptable toxicity
DRUG	Apatinib	Apatinib 250mg，d1-21，q3w, until disease progression or unacceptable toxicity
DRUG	Investigator chosen chemotherapy (ICC)	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.
RADIATION	Radiotherapy	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.

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-08-01
• Completion: 2026-08-01
• First posted: 2024-06-18
• Last updated: 2024-06-18

Locations

1 site across 1 country: China