QL1706 Plus Chemotherapy for Borderline Resectable Esophageal Cancer

NCT07283991 | Not Yet Recruiting Phase 2

• 2 other identifiers: RTS-028MR-31-25-068250
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  R0 resection rate confirmed by pathological evaluation.

  at 2 weeks post-surgery

Secondary Outcomes (4)

• major pathological response rate

  at 2 weeks post-surgery

• radiological response rate

  at 1 months post-treatment

• 3-year progression-free survival rate

  at 3 years post-treatment

• 3-year overall survival rate

  at 3 years post-treatment

Study Arms (1)

Aparolitolovureli plus chemotherapy group

EXPERIMENTAL

Drug: chemotherapy combined with Aparolitolovureli immunotherapy

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).

Aparolitolovureli plus chemotherapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed esophageal squamous cell carcinoma.
• Clinical stage cT4a, or at least one lymph node suspected of invading adjacent structures, or conglomerated/enlarged lymph nodes, or supraclavicular lymph node metastasis.
• No prior anti-tumor treatment before enrollment.
• Age ≥ 18 years.
• ECOG Performance Status score of 0-1.
• Signed written informed consent.

You may not qualify if:

• Presence of autoimmune disease.
• Requiring systemic corticosteroid therapy or other immunosuppressive medications.
• Symptomatic interstitial lung disease.
• Known hypersensitivity to the investigational drug(s).
• Pregnant or breastfeeding women.
• Patients of childbearing potential who refuse to use effective contraception.
• Prior treatment with immune checkpoint inhibitors or any agents targeting T-cell co-stimulatory/co-inhibitory pathways.
• Any condition deemed by the investigator to increase treatment risk or confound study outcome assessment.
• Prior esophageal cancer-related chemotherapy.

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Hecheng Li

CONTACT

021-021-64370045; lihecheng2000@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 16, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 1, 2029
• Last Updated: December 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: With publication
• Access Criteria: Interested investigators will be required to submit a formal letter of intent outlining research aims, rationale, and approach. Furthermore, documentation of local IRB approval, including a description of type of review, should be submitted with the data request.