QL1706 Plus Celecoxib in Advanced Esophageal Squamous Cell Carcinoma

NCT07049185 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: QL-ESCC-QIBA-30012025YJZ60
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-arm, Simon's two-stage phase II clinical trial to evaluate the efficacy and safety of QL1706 (a dual PD-1 and CTLA-4 antibody) combined with celecoxib in patients with advanced esophageal squamous cell carcinoma (ESCC) who progressed after prior immune checkpoint inhibitor therapy.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

immune Checkpoint Inhibitor; QL1706; Celecoxib; ESCC; ICI-resistant

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) as assessed by RECIST v1.1

  Objective Response Rate (ORR) per RECIST v1.1 at 6 months

  Up to 24 weeks from first dose

Secondary Outcomes (6)

• Progression-Free Survival (PFS)

  1 year

• Overall Survival (OS)

  1 year

• Duration of Response (DOR)

  1 year

• Time to Response (TTR)

  1 year

• Disease Control Rate (DCR)

  1 year

Study Arms (1)

Combination Therapy Group

EXPERIMENTAL

QL1706 Plus Celecoxib Group

Drug: QL1706 Plus Celecoxib Group

Interventions

QL1706 Plus Celecoxib Group DRUG

QL1706 (anti-PD-1/CTLA-4 bispecific antibody) will be administered at 5 mg/kg by intravenous infusion every 3 weeks. Celecoxib 200 mg will be taken orally twice daily starting on Day 1 of each 3-week treatment cycle. Treatment continues until disease progression, intolerable toxicity, or for a maximum of 2 years.

Combination Therapy Group

Eligibility Criteria

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

You may qualify if:

• Willing and able to provide written informed consent;
• Aged 18 to 75 years, inclusive;
• Histologically or cytologically confirmed unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC);
• Radiologically confirmed disease progression after at least 6 months of prior PD-1/PD-L1 inhibitor-based treatment;
• At least one measurable lesion per RECIST v1.1 criteria;
• Ability to swallow oral medication;
• ECOG performance status of 0-1;
• Estimated life expectancy ≥12 weeks;
• Adequate organ function (without blood transfusion or growth factors within 14 days prior to first dose), including:
• ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; TSH ≤ ULN; if abnormal, normal FT3/FT4 is acceptable; Total bilirubin ≤ 1.5 × ULN; ALT/AST ≤ 2.5 × ULN (≤ 5 × ULN if with liver metastases); ALP ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN or CrCl ≥ 50 mL/min; INR ≤ 1.5 (if not on anticoagulation);
• Non-sterilized women of childbearing potential and male participants with such partners must agree to use medically approved contraception during and for 3 months after study drug administration. Women must test negative for serum or urine HCG within 7 days prior to first dose and not be breastfeeding.

You may not qualify if:

• Any active autoimmune disease or history of autoimmune disease (e.g., autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism); exceptions: childhood asthma fully resolved without treatment or vitiligo;
• Currently using immunosuppressive therapy or systemic corticosteroids \>10 mg prednisone/day (or equivalent) within 2 weeks prior to enrollment;
• History of severe allergic reactions to monoclonal antibodies;
• Discontinued prior PD-1/PD-L1 therapy due to treatment-related toxicity;
• Prior exposure to anti-CTLA-4 therapy;
• History or evidence of interstitial lung disease or active non-infectious pneumonitis;
• Known active tuberculosis;
• Known CNS metastases, leptomeningeal disease, or spinal cord compression;
• Other malignancies within 5 years (excluding cured skin basal cell carcinoma or cervical carcinoma in situ);
• Clinically significant cardiac conditions (NYHA ≥ Class II heart failure, unstable angina, MI within 1 year, clinically significant arrhythmias requiring treatment, QTc \>450 ms for males or \>470 ms for females);
• Clinically significant bleeding within 3 months before enrollment or known bleeding tendency (positive fecal occult blood must be followed by endoscopy if persistent);
• Tumor invading major blood vessels or deemed likely to invade during the study;
• Patients with esophagotracheal or mediastinal fistulas;
• Clinically significant pleural/ascitic/pericardial effusion requiring drainage (if resolved and stable after drainage, enrollment is allowed);
• Arterial or venous thrombotic events within 6 months (e.g., stroke, DVT, PE);

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhihao Lu

CONTACT

010-88196561; pppeirain@126.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: June 22, 2025
• First Posted: July 3, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-07