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RecruitingNCT06908382Updated Apr 18, 2025

Neoadjuvant QL1706 Therapy for ESCC

A Phase 2 interventional study of Iparomlimab and Tuvonralimab Injection in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma, sponsored by Shandong Provincial Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-18.

Sponsored by Shandong Provincial Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study summary

This study plans to enroll 32 patients with resectable esophageal squamous cell carcinoma. The treatment regimen consists of Iparomlimab and Tuvonralimab(QL1706) combined with chemotherapy: intravenous infusion of QL1706 (5 mg/kg, q3w) in combination with albumin-bound paclitaxel (260 mg/m² on day 1, q3w) plus cisplatin (75 mg/m² on day 1, q3w) or carboplatin (AUC 5 on day 1, q3w) for 3 cycles. Surgical resection will be performed 3-6 weeks after treatment completion. Pre-treatment and surgical tissue specimens will be collected for analysis of tumor immune microenvironment changes using digital gene quantification technology. Peripheral blood samples will be obtained for dynamic ctDNA monitoring at four time points: within 7 days pre-treatment, 7 days pre-surgery, 7-30 days post-surgery, and 6 months post-surgery. The primary endpoint is the pathological complete response (pCR) rate, and secondary endpoints include major pathological response (MPR) and adverse reactions.

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Conditions studied

  • Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
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In context

Carcinoma

6,738 studies on the registry are indexed under Carcinoma; 1,159 are open to participants now.

This study's planned enrollment of 32 is below the median of 45 across 5,167 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Shandong Provincial Hospital is the lead sponsor of 58 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Signed written informed consent form to voluntarily join this study;
  2. Age 18-75 years old, male or female;
  3. ECOG PS 0-1;
  4. Planned surgical treatment after completion of neoadjuvant therapy;
  5. Patients with esophageal squamous cell carcinoma diagnosed pathologically as ct1b-ct2n+or ct3-ct4a any nm0

Exclusion criteria

Exclusion Criteria:

  1. The subject has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; the subject suffers from vitiligo; asthma has been completely relieved in childhood and does not need any intervention after adulthood can be included, but asthma that needs bronchodilators for medical intervention cannot be included);
  2. The subjects are using immunosuppressive agents or systemic or absorbable local hormones to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other effective hormones), and continue to use them within 2 weeks before enrollment;
  3. Severe allergic reaction to other monoclonal antibodies;
  4. There are cardiac clinical symptoms or diseases that are not well controlled, such as: (1) heart failure above NYHA grade 2 (2) unstable angina pectoris (3) myocardial infarction within one year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) qtc>450ms (male); Qtc>470ms (female);
  5. Patients at risk of massive bleeding
  6. Abnormal coagulation function (inr>1.5 or pt>16s), bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
  7. Genetic or known to exist Acquired hemorrhage and thrombotic tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or arteriovenous thrombosis events in recent 6 months (until the first use of shr-1210);
  8. Subjects with active infection or fever of unknown origin>38.5 degrees during screening and before the first administration;
  9. Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of lung function;
  10. Subjects with congenital or acquired immune deficiency (such as HIV infected), or active hepatitis (hepatitis B reference: HBV DNA detection value exceeds the upper limit of normal value; Hepatitis C reference: HCV virus titer or RNA detection value exceeds the upper limit of normal value);
  11. Those who have used other drugs in clinical trials within 4 weeks before the first medication;
  12. The subjects had previously or simultaneously suffered from other malignant tumors;
  13. Subjects may receive other systemic anti-tumor treatment during the study period;
  14. The subjects had previously received other PD-1 antibody therapy or other immunotherapy for PD-1/PD-L1;
  15. Live vaccines were administered less than 4 weeks before the study or during the study period;
  16. According to the judgment of the investigator, the subject has other factors that may lead to the forced termination of this study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    experimental group

    Drug: Iparomlimab and Tuvonralimab Injection

Interventions

  • DrugIparomlimab and Tuvonralimab Injection

    QL1706 (5 mg/kg, q3w) +Paclitaxel for injection (albumin bound) (260mg/m2 D1, q3w)+cisplatin (75mg/m2 D1, q3w)/carboplatin (AUC 5 D1) , 3 cycles

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What researchers measure

Primary outcomes

  1. pCR Rate

    The rate of patients with primary tumor and lymph nodes both achieved pathological complete response

    Time frame: one month after esophageal cancer surgery

Secondary outcomes

  1. MPR Rate

    The percentage of subjects with less than 10% tumor residue in the primary tumor site

    Time frame: one month after esophageal cancer surgery

  2. EFS

    The time from initial drug use to the occurrence of events as defined by the study protocol

    Time frame: approximately 5 years

  3. OS

    The time from initial drug use to death due to any cause

    Time frame: approximately 6 years

  4. Safety (adverse event)

    Rate of adverse event and severe event according to CTCAE 5.0

    Time frame: From initial drug use to one month after surgery

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Study locations

1 of 1 sites recruiting
  • Shandong Provincial Hospital
    Jinan, Shandong 250000, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06908382
Lead sponsor
Shandong Provincial Hospital
Responsible party
Yang Zhe (Tumor Research and Therapy Center, Shandong Provincial Hospital) — Principal investigator
First posted
Apr 3, 2025
Start date
Apr 28, 2025 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Apr 18, 2025

Study contacts

A Lei Feng
Contact
370100668@qq.com
+8613402214659

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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