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Esophageal Squamous Cell CarcinomaPhase 2QICE-ESCCNCT07049185

QL1706 Plus Celecoxib in Advanced Esophageal Squamous Cell Carcinoma

A Phase 2 study testing QL1706 Plus Celecoxib Group in people with Esophageal Squamous Cell Carcinoma, run by Peking University Cancer Hospital & Institute at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicenter，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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
QL1706 Plus Celecoxib Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
3 sitesChina
Study dates
17 Sep 2025to 1 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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);
  • Known congenital or acquired bleeding disorders;
  • Abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months;
  • 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);
  • Active infection or unexplained fever ≥38.5℃ within 7 days prior to first dose;
  • Known immunodeficiency (e.g., HIV); active HBV (HBsAg-positive with HBV DNA ≥ 2000 IU/mL); or active HCV infection;
  • Prior dual immunotherapy with PD-1 and CTLA-4 antibodies;
  • Significant bleeding history within 1 month (e.g., GI bleeding or vasculitis);
  • Live vaccine administration within 4 weeks prior to or planned during the study;
  • 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).

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhihao Lu contact

010-88196561

pppeirain@126.com

China3 sites, 3 recruiting

  • Beijing Cancer Hospital

    Beijing

    Zhihao Lu, 010-88196561, pppeirain@126.com

    Recruiting

  • Beijing GoBroad Hospital

    Beijing

    Yanshuo Cao, 400-696-2000, yanshuo.cao@bjmu.edu.cn

    Not yet recruiting

  • Peking University Shougang Hospital

    Beijing

    Xiaodong Wang, 010-57830000, xdwang2000@163.com

    Not yet recruiting

Other trials in China

About this study

Official title: A Single-Arm Clinical Trial of QL1706 Combined With Celecoxib in Patients With Advanced Esophageal Squamous Cell Carcinoma After Prior ICI Therapy

This is a multicenter，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.

Read the detailed description

The study aims to explore whether the combination of QL1706 and celecoxib can improve the objective response rate in ICI-refractory ESCC. Eligible patients will receive QL1706 (5 mg/kg IV Q3W) and celecoxib (200 mg BID orally) until disease progression, unacceptable toxicity, or up to 2 years. Safety, PFS, OS, and biomarkers such as PD-L1, HER2, IL-6, and IL-8 will also be evaluated.

Being tested
QL1706 Plus Celecoxib Group
Keywords
immune Checkpoint Inhibitor, QL1706, Celecoxib, ESCC, ICI-resistant
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QL1706 Plus Celecoxib GroupDrug

    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.

Study groups in NCT07049185
Study groupRoleWhat they receive
Combination Therapy GroupExperimentalQL1706 Plus Celecoxib Group
Receives: Drug: QL1706 Plus Celecoxib Group

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Up to 24 weeks from first dose

Secondary outcomes (6)

  1. Progression-Free Survival (PFS)

    Progression-Free Survival (PFS) defined as the time from the first dose to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: 1 year

  2. Overall Survival (OS)

    Overall Survival (OS) defined as the time from the first dose to death from any cause.

    Measured: 1 year

  3. Duration of Response (DOR)

    Duration of Response (DOR) for participants who achieve a complete response (CR) or partial response (PR), measured from the first documented response until documented disease progression per RECIST v1.1 or death.

    Measured: 1 year

  4. Time to Response (TTR)

    Time to Response (TTR) defined as the time from the first dose to the first documented objective response (CR or PR) per RECIST v1.1.

    Measured: 1 year

  5. Disease Control Rate (DCR)

    Disease Control Rate (DCR) defined as the percentage of participants achieving CR, PR, or stable disease (SD) as per RECIST v1.1.

    Measured: 1 year

  6. Safety Assessment

    Incidence and severity of adverse events as assessed by CTCAE v5.0.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2025
  2. Study start17 Sep 2025
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07049185
Sponsor's protocol ID
QL-ESCC-QIBA-3001
Other IDs
2025YJZ60
Acronym
QICE-ESCC
Status last verified
Oct 2026
First submitted
22 Jun 2025
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QL1706 Plus Celecoxib Group in people with Esophageal Squamous Cell Carcinoma, run by Peking University Cancer Hospital & Institute at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhihao Lu (010-88196561, pppeirain@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) as assessed by RECIST v1.1 (time frame: Up to 24 weeks from first dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07049185.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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