Locally Advanced Resectable Esophageal Squamous Cell CarcinomaPhase 2NCT06908382
Neoadjuvant QL1706 Therapy for ESCC
A Phase 2 study testing Iparomlimab and Tuvonralimab Injection in people with Locally Advanced Resectable Esophageal Squamous Cell Carcinoma, run by Shandong Provincial Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
- What is being tested?
- Iparomlimab and Tuvonralimab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2025to 31 Dec 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
- 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;
- Patients with esophageal squamous cell carcinoma diagnosed pathologically as ct1b-ct2n+or ct3-ct4a any nm0
Who cannot join
- 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);
- Patients at risk of massive bleeding
- Abnormal coagulation function (inr>1.5 or pt>16s), bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
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- 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);
- Subjects with active infection or fever of unknown origin>38.5 degrees during screening and before the first administration;
- Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of lung function;
- 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);
- Those who have used other drugs in clinical trials within 4 weeks before the first medication;
- The subjects had previously or simultaneously suffered from other malignant tumors;
- Subjects may receive other systemic anti-tumor treatment during the study period;
- The subjects had previously received other PD-1 antibody therapy or other immunotherapy for PD-1/PD-L1;
- Live vaccines were administered less than 4 weeks before the study or during the study period;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250000
About this study
Official title: A Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Chemotherapy as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
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.
- Being tested
- Iparomlimab and Tuvonralimab Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab InjectionDrug
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
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Drug: Iparomlimab and Tuvonralimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR Rate
The rate of patients with primary tumor and lymph nodes both achieved pathological complete response
Measured: one month after esophageal cancer surgery
Secondary outcomes (4)
MPR Rate
The percentage of subjects with less than 10% tumor residue in the primary tumor site
Measured: one month after esophageal cancer surgery
EFS
The time from initial drug use to the occurrence of events as defined by the study protocol
Measured: approximately 5 years
OS
The time from initial drug use to death due to any cause
Measured: approximately 6 years
Safety (adverse event)
Rate of adverse event and severe event according to CTCAE 5.0
Measured: From initial drug use to one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start28 Apr 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Resectable Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yang Zhe, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908382
- Sponsor's protocol ID
- SWYX-20241055
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Chemotherapy as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06908382
- Acronym / sponsor ID
- SWYX-20241055
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 28 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Iparomlimab and Tuvonralimab Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
- Patients with esophageal squamous cell carcinoma diagnosed pathologically as ct1b-ct2n+or ct3-ct4a any nm0
Key exclusion criteria (16 listed)
- 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);
- Patients at risk of massive bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iparomlimab and Tuvonralimab InjectionQL1706 (5 mg/kg, q3w) +Paclitaxel for injection (albumin bound) (260mg/m2 D1, q3w)+cisplatin (75mg/m2 D1, q3w)/carboplatin (AUC 5 D1) ， 3 cycles | Drug | experimental group |
Primary outcome
pCR Rate
Time frame: one month after esophageal cancer surgery
The rate of patients with primary tumor and lymph nodes both achieved pathological complete response
4 secondary outcomes
MPR Rate
Time frame: one month after esophageal cancer surgery
EFS
Time frame: approximately 5 years
OS
Time frame: approximately 6 years
Safety (adverse event)
Time frame: From initial drug use to one month after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab and Tuvonralimab Injection in people with Locally Advanced Resectable Esophageal Squamous Cell Carcinoma, run by Shandong Provincial Hospital at 1 site 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 5 inclusion and 16 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 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 A Lei Feng (+8613402214659, 370100668@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR Rate (time frame: one month after esophageal cancer surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2025.