QL1706Phase 2NCT07533305
Efficacy and Safety of QL1706 Combined With Nab-paclitaxel and Cisplatin as 1st Line Therapy for Advanced or Metastatic Esophageal Squamous Cell Carcinoma
A Phase 2 study testing QL1706 plus nab-paclitaxel and cisplatin in people with QL1706 and ESCC, run by The First Affiliated Hospital of Henan University of Science and Technology.
Trial summary
The purpose of this study is to assess the efficacy and safety of QL1706 combined with nab-paclitaxel and cisplatin in first-line therapy for patients with advanced or metastatic esophageal squamous cell carcinoma. QL1706 is a anti-PD-1 and anti-CTLA4 antibody. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- QL1706, ESCC, First-line Therapy
- What is being tested?
- QL1706 plus nab-paclitaxel and cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 30 Jun 2029
- 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
- Subjects participate voluntarily and sign informed consent.
- 18-75 years, male or female.
- Histologically confirmed Unresectable Advanced or metastatic Esophageal Squamous Cell Carcinomas
- No previous systemic anti-tumor treatment for unresectable locally advanced or metastatic esophageal squamous cell carcinoma has been received
- At least 1 measurable target lesion and/or unmeasurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).
- ECOG PS 0-1
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- Expected survival ≥ 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; Total bilirubin ≤ 1.5 × ULN; ALT/AST ≤ 2.5 × ULN (≤ 5 × ULN if with liver or bone metastases); ALP ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN; 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
- Have received anti-PD-1 or anti-PD-L1 antibody therapy;
- BMI < 18.5 kg/m2 or weight loss ≥ 10% within 2 months before screening (at the same time, the effect of a large amount of pleural effusions and ascites on bogy weight should be considered);
- Presence of any active autoimmune disease or history of autoimmune disease (such as: Autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism)
- Those who are taking immunosuppressants or systemic hormonal therapy for immunosuppressive purposes (dose> 10 mg/day prednisone or other equivalent cortiremonial hormones)
- Severe allergic reaction to other monoclonal antibodies
- Known history or evidence of interstitial lung disease or active non-infectious pneumonia
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- Known central nervous system metastases
- History of other malignancies within the past 5 years or concurrent malignancies (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
- Uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA class II or higher heart failure (2) unstable angina (3) myocardial infarction within the past year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) QTc > 450 ms (male); QTc > 470 ms (female)
- Tumor invasion of major blood vessels, or based on imaging, the investigator determines a high likelihood of tumor invasion of major blood vessels during the study period, which may lead to fatal bleeding, such as imaging evidence of >90-degree encasement of major vessels or tumor cavitation
- Patients with pleural effusion, ascites, or pericardial effusion requiring drainage; if the symptoms are stable after drainage as assessed by the investigator, enrollment is possible. Gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the start of study treatment.
- Major surgical procedures within 4 weeks prior to the start of study treatment (diagnostic procedures excluded) or anticipated need for major surgery during the study period.
- Active infection, unexplained fever ≥38.5°C within 7 days prior to drug administration, or baseline white blood cell count >15×109/L.
- Congenital or acquired immunodeficiency (e.g., HIV infection); hepatitis B surface antigen (HBsAg) positive with hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥2000 IU/ml, or positive for hepatitis C virus antibody.
- Live vaccine administration within 4 weeks prior to study drug administration or during the study period.
- As judged by the investigator, other factors that may affect study outcomes or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases (including psychiatric disorders) requiring concurrent treatment, significant laboratory abnormalities, or family or social factors that may impact patient safety.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-arm Clinical Study of QL1706 (Anti PD-1 and CTLA-4 Antibody) in Combination With Nab-paclitaxel and Cisplatin as First-line Therapy in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma
The purpose of this study is to assess the efficacy and safety of QL1706 combined with nab-paclitaxel and cisplatin in first-line therapy for patients with advanced or metastatic esophageal squamous cell carcinoma. QL1706 is a anti-PD-1 and anti-CTLA4 antibody.
- Conditions
- QL1706, ESCC, First-line Therapy
- Being tested
- QL1706 plus nab-paclitaxel and cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706 plus nab-paclitaxel and cisplatinDrug
QL1706 will be administrated at a dose of 5 mg/kg intravenously (IV), every 3 weeks, until progressive disease or intolerable or other reasons according to the criteria for termination of treatment). QL1706 will be administrated up to 2 year.
Nab-paclitaxel will be administrated at a dose of 125mg/m2 intravenously (IV), d1,d8, every 3 weeks for 6 cycles at most.
Cisplatin will be administrated at a dose of 75mg/m2 intravenously (IV), every 3 weeks for 6 cycles at most.
| Study group | Role | What they receive |
|---|---|---|
| QL1706 plus nab-paclitaxel and cisplatin | Experimental | Not described Receives: Drug: QL1706 plus nab-paclitaxel and cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST 1.1 assessed by the investigators.
Measured: From the date of first dose to achieving complete response or partial response, assessed up to 42 months
Secondary outcomes (4)
PFS
PFS is defined as the time from the first administration to the first documented progressive disease (PD) per RECIST 1.1 by investigators or death due to any cause, whichever occurs first
Measured: From the date of first dose to the date of first documented progression or death from any cause, whichever occurs first, assessed up to 42 months.
OS
OS is defined as the time from the first administration to death due to any cause
Measured: From the date of first dose to the date of death due to any cause, assessed up to 48months.
DOR
DOR is defined for participants who demonstrate a confirmed CR or PR, per RECIST 1.1 by the investigators
Measured: From the date of first documented evidence of CR or PR to the date of PD or death, assessed up to 42 months.
number of participants with AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: From first dose to the later of 90 days after the last dose of QL1706 or 30 days after the last dose of nab-paclitaxel or cisplatin, assessed up to 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QL1706Studies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shan TY, The First Affiliated Hospital of Henan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533305
- Sponsor's protocol ID
- QL-ESCC-QIBA-1002
- Status last verified
- Oct 2025
- First submitted
- 3 Mar 2026
- Last updated
- 16 Apr 2026
- 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Clinical Study of QL1706 (Anti PD-1 and CTLA-4 Antibody) in Combination With Nab-paclitaxel and Cisplatin as First-line Therapy in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07533305
- Acronym / sponsor ID
- QL-ESCC-QIBA-1002
- Conditions
- QL1706, ESCC, First-line Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 16 Apr 2026 (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.
The purpose of this study is to assess the efficacy and safety of QL1706 combined with nab-paclitaxel and cisplatin in first-line therapy for patients with advanced or metastatic esophageal squamous cell carcinoma. QL1706 is a anti-PD-1 and anti-CTLA4 antibody.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QL1706 plus nab-paclitaxel and cisplatin | Experimental | Drug: QL1706 plus nab-paclitaxel and cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects participate voluntarily and sign informed consent.
- 18-75 years, male or female.
- Histologically confirmed Unresectable Advanced or metastatic Esophageal Squamous Cell Carcinomas
- No previous systemic anti-tumor treatment for unresectable locally advanced or metastatic esophageal squamous cell carcinoma has been received
- At least 1 measurable target lesion and/or unmeasurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).
Key exclusion criteria (16 listed)
- Have received anti-PD-1 or anti-PD-L1 antibody therapy;
- BMI < 18.5 kg/m2 or weight loss ≥ 10% within 2 months before screening (at the same time, the effect of a large amount of pleural effusions and ascites on bogy weight should be considered);
- Presence of any active autoimmune disease or history of autoimmune disease (such as: Autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism)
- Those who are taking immunosuppressants or systemic hormonal therapy for immunosuppressive purposes (dose> 10 mg/day prednisone or other equivalent cortiremonial hormones)
- Severe allergic reaction to other monoclonal antibodies
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 |
|---|---|---|
| QL1706 plus nab-paclitaxel and cisplatinQL1706 will be administrated at a dose of 5 mg/kg intravenously (IV), every 3 weeks, until progressive disease or intolerable or other reasons according to the criteria for termination of treatment). QL1706 will be administrated up to 2 year. Nab-paclitaxel will be administrated at a dose of 125mg/m2 intravenously (IV), d1,d8, every 3 weeks for 6 cycles at most. Cisplatin will be administrated at a dose of 75mg/m2 intravenously (IV), every 3 weeks for 6 cycles at most. | Drug | QL1706 plus nab-paclitaxel and cisplatin |
Primary outcome
ORR
Time frame: From the date of first dose to achieving complete response or partial response, assessed up to 42 months
ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST 1.1 assessed by the investigators.
4 secondary outcomes
PFS
Time frame: From the date of first dose to the date of first documented progression or death from any cause, whichever occurs first, assessed up to 42 months.
OS
Time frame: From the date of first dose to the date of death due to any cause, assessed up to 48months.
DOR
Time frame: From the date of first documented evidence of CR or PR to the date of PD or death, assessed up to 42 months.
number of participants with AEs
Time frame: From first dose to the later of 90 days after the last dose of QL1706 or 30 days after the last dose of nab-paclitaxel or cisplatin, assessed up to 48 months.
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 16 Apr 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QL1706 plus nab-paclitaxel and cisplatin in people with QL1706 and ESCC, run by The First Affiliated Hospital of Henan University of Science and Technology.
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 9 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: opening soon, as of the sponsor's last update on 16 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?
Contact Shegan Gao Professor Gao (+86 0379-64830815, gsg112258@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: From the date of first dose to achieving complete response or partial response, assessed up to 42 months). 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 16 Apr 2026.