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Local Advanced Esophageal CancerPhase 2NCT07530549

A Phase II Single-arm Clinical Study in the Treatment of Locally Advanced Esophageal Cancer After Failed Neoadjuvant Chemoimmunotherapy

A Phase 2 study testing QL1706 in people with Local Advanced Esophageal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

The goal of this clinical trial is Iparomlimab and tuvonralimab (QL1706) combined with chemoradiotherapy in the treatment of locally advanced esophageal cancer after failed neoadjuvant chemoimmunotherapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Local Advanced Esophageal Cancer
What is being tested?
QL1706
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
1 Apr 2026to 31 Aug 2028
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

  • Age 18 to 75 years, male or female;
  • Histologically confirmed locally advanced squamous cell carcinoma or adenocarcinoma of the esophagus or esophagogastric junction;
  • ECOG performance status 0-1; ④ Failure of or local progression after 2-4 cycles of first-line chemotherapy combined with immunotherapy, or deemed unresectable by surgical evaluation;
  • ⑤ At least one measurable lesion according to RECIST v1.1 criteria;
  • ⑥ Adequate major organ and bone marrow function: Hematology: Hemoglobin (Hb) ≥90 g/L (without transfusion within 14 days); Absolute neutrophil count (NEUT) ≥1.5×10⁹/L; Platelets (PLT) ≥100×10⁹/L; Biochemistry: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN in cases of liver metastases); Total bilirubin (TBIL) ≤2×ULN; Serum albumin (ALB) ≥28 g/L; Serum creatinine (Cr) ≤1.5×ULN and creatinine clearance >50 μmol/L; Coagulation: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN (unless the subject is receiving anticoagulant therapy and INR and APTT are within the expected therapeutic range);
  • ⑦ Effective contraception during the study period;
  • Voluntary participation in this study with signed informed consent and good compliance.

Who cannot join

  • Active bleeding or high risk of bleeding (as assessed by the investigator);
  • Patients requiring systemic anti-infective therapy;
  • Concurrent primary malignant tumors other than esophageal cancer (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
  • Presence of brainstem, leptomeningeal metastasis, spinal cord metastasis, or compression;
  • Complicated with severe cardiovascular diseases, such as uncontrolled heart failure, coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction within the past 5 years; and complicated with other uncontrolled acute or chronic diseases;
  • Positive for human immunodeficiency virus antibody (HIVAb), active tuberculosis, active hepatitis B virus infection (HBsAg positive and HBV-DNA > 500 IU/ml or the upper limit of normal, whichever is higher), or active hepatitis C virus infection (HCV antibody positive and HCV-RNA > lower limit of detection);
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  • Known allergy to any component of any study drug; known history of severe hypersensitivity reactions to other monoclonal antibodies; ⑧ Adverse reactions from prior immunotherapy not fully recovered;
  • Receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation, or other topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first study drug administration;
  • ⑩ Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to study administration. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;
  • ⑪ Known history of mental illness, substance abuse, alcoholism, or drug addiction;
  • ⑫ Pregnant or breastfeeding women;
  • ⑬ Other conditions deemed unsuitable for participation in this study by the investigator, including but not limited to poor patient compliance, intolerance, etc.

About this study

Official title: Iparomlimab and Tuvonralimab Combined With Chemoradiotherapy in the Treatment of Locally Advanced Esophageal Cancer After Failed Neoadjuvant Chemoimmunotherapy: a Prospective, Single-arm, Multicenter, Phase II Clinical Study

The goal of this clinical trial is Iparomlimab and tuvonralimab (QL1706) combined with chemoradiotherapy in the treatment of locally advanced esophageal cancer after failed neoadjuvant chemoimmunotherapy. The main question it aims to answer is： Can it bring survival benefits and safet to patients？Subsequent evaluation will determine whether the patient undergoes surgical treatment. Follow-up will be conducted to assess the efficacy and safety of the treatment。

Read the detailed description

Participants were treated with QL1706 and radical CCRT.After receiving the combination of QL1706 with radical CCRT, patients who are eligible for surgery will undergo the procedure, while those who are not candidates for surgery may receive sequential boost radiotherapy to PGTV at a about dose of 60 Gy. Following radiotherapy, maintenance treatment with immunotherapy combined with chemotherapy will be administered for up to one year, until disease progression, death, or the occurrence of intolerable toxicity.

Being tested
QL1706
Keywords
Esophageal cancer, QL1706, concurrent chemoradiotherapy, chemoradiotherapy, Immunotherapy
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • QL1706Drug

    Also called radical CCRT

    QL1706(Iparomlimab and Tuvonralimab Injection): 5.0 mg/kg Q3W for 2 cycles; Radiotherapy Prescription Dose: 95% PGTV 40-50 Gy/20-25 fractions; Tegafur: 40-60 mg/m² twice daily (d1-14) every 3 weeks for 2 cycles; Evaluation for surgery: Patients will be divided into surgical and non-surgical groups. Participants who are not candidates for surgery may receive sequential boost radiotherapy to PGTV at a about dose of 60 Gy. Following radiotherapy, maintenance treatment with immunotherapy combined with chemotherapy will be administered for up to one year, until disease progression, death, or the occurrence of intolerable toxicity.

Study groups in NCT07530549
Study groupRoleWhat they receive
Group1ExperimentalQL1706 and radical CCRT
Receives: Drug: QL1706

What is being measured

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

  1. Event-free Survival(EFS)

    time from treatment to disease progression, local or distant recurrence, or death

    Measured: From enrollment to the end of monitoring at 2 years

Secondary outcomes (3)

  1. Overall Survival (OS)

    The time from the start of treatment to death from any cause

    Measured: From enrollment to the end of monitoring at 2 years

  2. Progression-Free Survival(PFS)

    time from treatment to the first documented disease progression or death

    Measured: From enrollment to the end of monitoring at 2 years

  3. Adverse reaction

    Measured: From the start of treatment to within 90 days after the end of treatment.

Timeline

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

  1. First posted15 Apr 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Aug 2028 (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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07530549
Sponsor's protocol ID
NCC5675
Status last verified
Apr 2026
First submitted
16 Mar 2026
Last updated
15 Apr 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 in people with Local Advanced Esophageal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free Survival(EFS) (time frame: From enrollment to the end of monitoring at 2 years). 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 NCT07530549.

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 15 Apr 2026.

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