Health TrialsbyHealthPanel

Neoadjuvant QL1706 Therapy for ESCC

ConditionLocally Advanced Resectable Esophageal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong Provincial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed written informed consent form to voluntarily join this study;

Age 18-75 years old, male or female;

ECOG PS 0-1;

Planned surgical treatment after completion of neoadjuvant therapy;

Disqualifiers

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);

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;

Severe allergic reaction to other monoclonal antibodies;

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);

Trial design

Design model

Single group

Treatments tested in this trial

  • Iparomlimab and Tuvonralimab Injection

    Drug

    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

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: experimental groupExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Provincial Hospital

Lead sponsor

Source ClinicalTrials.gov
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