A Phase II Study of CRT Combined With QL1706 in ESCC Patients

NCT05490719 | Recruiting Phase 2

• 1 other identifier: QL1706-IIT-02
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm, multi-center Phase II Study. This clinical study is an investigator-initiated clinical trial（IIT). The objective of this study is to evaluate the efficacy and safety of Chemoradiationtherapy combined with QL1706 (anti-CTLA-4 and PD-1 antibody) in patients with unresectable locally advanced esophageal squamous cell carcinoma.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Esophageal Cancer; Concurrent chemoradiation; Immunotherapy; CTLA-4; PD-1; QL1706

Outcome Measures

Primary Outcomes (1)

• PFS assessed by investigators

  Progression-free survival assessed by investigators

  Up to approximately 2 years.

Secondary Outcomes (4)

• OS

  1year and 3years

• ORR

  Up to approximately 2 years

• DoR

  Up to approximately 2 years

• The rates and severity of Adverse Events, Serious Adverse Events

  Through study completion, up to approximately 2 years

Study Arms (1)

QL1706 plus Chemotherapy and Radiotherapy

EXPERIMENTAL

Radiotherapy: Total 50.4Gy/28 fraction ,1.8Gy per time，5 fractions per week. QL1706 will be administered at a dose of 5 mg/kg intravenously (IV), every 3 weeks, until progressive disease or intolerable or other reasons according to the criteria for termination of treatment). QL1706 will be administered up to 1 year. Chemotherapy: Taxol 135 mg/m2, days 1, 22; Cisplatin 25 mg/m2, day 1-3, day 22-24.

Drug: QL1706

Interventions

QL1706 DRUG

QL1706 is a humanized anti-PD1 IgG4 and anti-CTLA-4 IgG4 antibody.

Also known as: Radiation, Taxol, Cisplatin

QL1706 plus Chemotherapy and Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects participate voluntarily and sign informed consent.
• age:18-75 years, male or female.
• Histologically confirmed Advanced Unresectable Esophageal Squamous Cell Carcinomas,unresectable of clinical stage II-IVa patients (include unresectable,or surgical contraindication or refuse surgery)(According to AJCC 8th Edition stage , Pre-treatment clinical stage cT1N2-3M0,cT2-4bN0-3M0.
• At least 1 measurable target lesion and/or unmeasurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).

You may not qualify if:

• Patients who have a history of esophageal cancer surgery.
• Previous history of fistula caused by primary tumor infiltration.
• a high risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation.
• Subjects with poor nutritional status and weight loss of ≥ 10% in the first 2 months of screening have no significant improvement after nursing intervention.
• Major surgery or serious trauma within 4 weeks before the first use of the study drug.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin cancer hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (1)

• Zhang W, Zhang T, Chen X, Li J, Gao L, Jiang S, Wang Y, Zheng Z, Dong J, Li Z, Zhao G, Cao F, Bai N, Wang P, Yan C, Pang Q. Iparomlimab and tuvonralimab (QL1706) combined definitive chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma (QL1706-IIT-02): a single arm, phase 2 trial. EClinicalMedicine. 2026 Jan 21;92:103758. doi: 10.1016/j.eclinm.2026.103758. eCollection 2026 Feb.

  PMID: 41623855 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms; Diabetes Mellitus, Insulin-Dependent, 12

Interventions

Radiation; Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Qingsong Pang

CONTACT

0862223340123; pangqingsong2013@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: August 8, 2022
• Study Start: August 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

CN (1)