QL1706 plus celecoxib in advanced ESCC that progressed after prior immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, single-arm phase II trial using Simon's two-stage design to evaluate the activity and safety of QL1706 (a dual PD-1/CTLA-4 antibody) plus celecoxib in patients with advanced ESCC after progression on previous immune checkpoint inhibitors. Patients receive QL1706 5 mg/kg IV every 3 weeks and celecoxib 200 mg twice daily until progression, unacceptable toxicity, or up to two years, with safety, progression-free survival, overall survival, and exploratory biomarkers monitored. Primary focus is on objective response rate, with secondary endpoints including duration of response and biomarker dynamics such as PD-L1, HER2, IL-6, and IL-8. The trial is designed to determine if this combination can overcome ICI-refractory disease and provide a meaningful clinical benefit.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Willing and able to provide written informed consent;
2. Aged 18 to 75 years, inclusive;
3. Histologically or cytologically confirmed unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC);
4. Radiologically confirmed disease progression after at least 6 months of prior PD-1/PD-L1 inhibitor-based treatment;
5. At least one measurable lesion per RECIST v1.1 criteria;
6. Ability to swallow oral medication;
7. ECOG performance status of 0-1;
8. Estimated life expectancy ≥12 weeks;
9. 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);
10. 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.

Exclusion Criteria：

1. 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;
2. Currently using immunosuppressive therapy or systemic corticosteroids \>10 mg prednisone/day (or equivalent) within 2 weeks prior to enrollment;
3. History of severe allergic reactions to monoclonal antibodies;
4. Discontinued prior PD-1/PD-L1 therapy due to treatment-related toxicity;
5. Prior exposure to anti-CTLA-4 therapy;
6. History or evidence of interstitial lung disease or active non-infectious pneumonitis;
7. Known active tuberculosis;
8. Known CNS metastases, leptomeningeal disease, or spinal cord compression;
9. Other malignancies within 5 years (excluding cured skin basal cell carcinoma or cervical carcinoma in situ);
10. 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);
11. Clinically significant bleeding within 3 months before enrollment or known bleeding tendency (positive fecal occult blood must be followed by endoscopy if persistent);
12. Tumor invading major blood vessels or deemed likely to invade during the study;
13. Patients with esophagotracheal or mediastinal fistulas;
14. Clinically significant pleural/ascitic/pericardial effusion requiring drainage (if resolved and stable after drainage, enrollment is allowed);
15. Arterial or venous thrombotic events within 6 months (e.g., stroke, DVT, PE);
16. Known congenital or acquired bleeding disorders;
17. Abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months;
18. Prior radiotherapy, chemotherapy, or surgery within 4 weeks prior to first study dose (except bone metastasis palliative radiotherapy); biologics within 4 weeks; targeted therapy within 5 half-lives; unresolved toxicities ≥ Grade 2 (except alopecia);
19. Active infection or unexplained fever ≥38.5℃ within 7 days prior to first dose;
20. Known immunodeficiency (e.g., HIV); active HBV (HBsAg-positive with HBV DNA ≥ 2000 IU/mL); or active HCV infection;
21. Prior dual immunotherapy with PD-1 and CTLA-4 antibodies;
22. Significant bleeding history within 1 month (e.g., GI bleeding or vasculitis);
23. Live vaccine administration within 4 weeks prior to or planned during the study;
24. Other conditions deemed by the investigator to interfere with participation or study results (e.g., substance abuse, psychiatric disorders, severe lab abnormalities, or social/family limitations).

Where it's running

• Beijing Cancer Hospital
  Beijing, China Recruiting
• Beijing GoBroad Hospital
  Beijing, China Not yet recruiting
• Peking University Shougang Hospital
  Beijing, China Not yet recruiting

Study contacts

• Study coordinator: Zhihao Lu
• Email: pppeirain@126.com
• Phone: 010-88196561

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.