QL1706 Plus Chemotherapy for Borderline Resectable Esophageal Cancer

Sponsor
Ruijin Hospital
Study ID
NCT07283991
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • chemotherapy combined with Aparolitolovureli immunotherapy — DRUG
    After enrollment, patients will receive first-stage treatment consisting of cisplatin plus nanoparticle albumin-bound paclitaxel chemotherapy combined with Aparolitolovureli immunotherapy for 2 to 4 cycles. If the tumor is assessed as resectable, radical esophagectomy will be performed. If the tumor remains unresectable, definitive concurrent chemoradiotherapy will be administered. Following radical esophagectomy, patients will enter the second stage of treatment with Aparolitolovureli maintenance immunotherapy for up to 1 year (a maximum of 14 cycles during the maintenance phase).

Study Details

China bears a disproportionately high burden of esophageal cancer, accounting for approximately 50% of newly diagnosed cases worldwide, with an average 5-year survival rate of only 30%. Esophageal adenocarcinoma and squamous cell carcinoma (ESCC) are the major pathological subtypes, among which squamous cell carcinoma predominates in Asian populations. More than 90% of esophageal cancer cases in China are ESCC. Optimal treatment for locally advanced esophageal cancer remains a matter of debate. Findings from Japanese clinical studies such as JCOG1109 have demonstrated that neoadjuvant chemotherapy can significantly improve long-term survival in patients with locally advanced ESCC. Neoadjuvant chemotherapy followed by surgery has therefore become one of the preferred treatment strategies. Preclinical evidence suggests synergistic interactions between chemotherapy and immunotherapy, potentially enhancing treatment efficacy. Moreover, clinical trials such as ESCORT-NEO and NCCES01 have validated the safety and effectiveness of immunochemotherapy for locally advanced esophageal cancer. Consequently, chemotherapy combined with immunotherapy has emerged as a promising approach for improving survival outcomes in this patient population. A Phase II clinical trial involving the investigational drug Aparolitolovureli was conducted in 39 patients with unresectable locally advanced ESCC, evaluating a regimen of radical chemoradiotherapy combined with immunotherapy followed by Aparolitolovureli maintenance. The study reported a median progression-free survival (mPFS) of 13.99 months, with 12-month PFS and OS rates of 62.1% and 86.2%, respectively, demonstrating encouraging efficacy. These results, together with supporting preclinical data, suggest that immunochemotherapy is both feasible and effective in locally advanced esophageal cancer. Based on this foundation, our research team proposes a single-arm clinical study in patients with borderline resectable locally advanced ESCC. A total of 24 participants will receive 2-4 cycles of inductive immunochemotherapy with Aparolitolovureli plus cisplatin and paclitaxel. Patients deemed resectable after reassessment will undergo radical esophagectomy, followed by Aparolitolovureli maintenance therapy. The study aims to evaluate the efficacy and safety of this treatment strategy and provide scientific evidence and clinical guidance to improve the overall prognosis of patients with ESCC.

Key Dates

First listed
Dec 16, 2025
Start date
Dec 30, 2025
Status verified
Oct 2025
Primary completion
Aug 30, 2026
Completion
Aug 1, 2029

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Aparolitolovureli plus chemotherapy group

Primary Outcome Measure

R0 resection rate [ Time Frame: at 2 weeks post-surgery ]

Central Contacts

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