Esophageal Squamous Cell CarcinomaPhase 2NCT05490719
A Phase II Study of CRT Combined With QL1706 in ESCC Patients
A Phase 2 study testing QL1706 in people with Esophageal Squamous Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a single arm, multi-center Phase II Study. This clinical study is an investigator-initiated clinical trial（IIT). The objective of this study is to evaluate the efficacy and safety of Chemoradiationtherapy combined with QL1706 (anti-CTLA-4 and PD-1 antibody) in patients with unresectable locally advanced… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- 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
- 39 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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.
- age:18-75 years, male or female.
- Histologically confirmed Advanced Unresectable Esophageal Squamous Cell Carcinomas,unresectable of clinical stage II-IVa patients (include unresectable,or surgical contraindication or refuse surgery)(According to AJCC 8th Edition stage , Pre-treatment clinical stage cT1N2-3M0,cT2-4bN0-3M0.
- At least 1 measurable target lesion and/or unmeasurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).
Who cannot join
- Patients who have a history of esophageal cancer surgery.
- Previous history of fistula caused by primary tumor infiltration.
- a high risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation.
- Subjects with poor nutritional status and weight loss of ≥ 10% in the first 2 months of screening have no significant improvement after nursing intervention.
- Major surgery or serious trauma within 4 weeks before the first use of the study drug.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin cancer hospital
Tianjin, Tianjin Municipality, 300060
Qingsong Pang
About this study
Official title: A Single Arm, Phase II Clinical Study of Chemoradiationtherapy Combined With QL1706 (Anti-CTLA-4 and PD-1 Antibody) in Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
This is a single arm, multi-center Phase II Study. This clinical study is an investigator-initiated clinical trial（IIT). The objective of this study is to evaluate the efficacy and safety of Chemoradiationtherapy combined with QL1706 (anti-CTLA-4 and PD-1 antibody) in patients with unresectable locally advanced esophageal squamous cell carcinoma.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- QL1706
- Keywords
- Esophageal Cancer, Concurrent chemoradiation, Immunotherapy, CTLA-4, PD-1, QL1706
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms, Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706Drug
Also called Radiation, Taxol, Cisplatin
QL1706 is a humanized anti-PD1 IgG4 and anti-CTLA-4 IgG4 antibody.
| Study group | Role | What they receive |
|---|---|---|
| QL1706 plus Chemotherapy and Radiotherapy | Experimental | Radiotherapy: Total 50.4Gy/28 fraction ,1.8Gy per time，5 fractions per week.
QL1706 will be administered 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 administered up to 1 year.
Chemotherapy: Taxol 135 mg/m2, days 1, 22; Cisplatin 25 mg/m2, day 1-3, day 22-24. Receives: Drug: QL1706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS assessed by investigators
Progression-free survival assessed by investigators
Measured: Up to approximately 2 years.
Secondary outcomes (4)
OS
Overall survival
Measured: 1year and 3years
ORR
Objective Response Rate，Complete Response plus Partial Response
Measured: Up to approximately 2 years
DoR
Duration of Response
Measured: Up to approximately 2 years
The rates and severity of Adverse Events, Serious Adverse Events
The rates and severity of Adverse Events, Serious Adverse Events
Measured: Through study completion, up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Aug 2022
- Primary completion1 Sep 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- 39 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490719
- Sponsor's protocol ID
- QL1706-IIT-02
- Status last verified
- May 2024
- First submitted
- 11 Jul 2022
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang W, Zhang T, Chen X, Li J, Gao L, Jiang S, Wang Y, Zheng Z, Dong J, Li Z, Zhao G, Cao F, Bai N, Wang P, Yan C, Pang Q. Iparomlimab and tuvonralimab (QL1706) combined definitive chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma (QL1706-IIT-02): a single arm, phase 2 trial. EClinicalMedicine. 2026 Jan 21;92:103758. doi: 10.1016/j.eclinm.2026.103758. eCollection 2026 Feb.
PubMed 41623855
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Phase II Clinical Study of Chemoradiationtherapy Combined With QL1706 (Anti-CTLA-4 and PD-1 Antibody) in Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05490719
- Acronym / sponsor ID
- QL1706-IIT-02
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Esophageal Cancer, Concurrent chemoradiation, Immunotherapy, CTLA-4, PD-1, QL1706
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 8 Aug 2022 (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 is a single arm, multi-center Phase II Study. This clinical study is an investigator-initiated clinical trial（IIT). The objective of this study is to evaluate the efficacy and safety of Chemoradiationtherapy combined with QL1706 (anti-CTLA-4 and PD-1 antibody) in patients with unresectable locally advanced esophageal squamous cell carcinoma.
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 Chemotherapy and Radiotherapy | Experimental | Drug: QL1706Radiotherapy: Total 50.4Gy/28 fraction ,1.8Gy per time，5 fractions per week. QL1706 will be administered 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 administered up to 1 year. Chemotherapy: Taxol 135 mg/m2, days 1, 22; Cisplatin 25 mg/m2, day 1-3, day 22-24. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects participate voluntarily and sign informed consent.
- age:18-75 years, male or female.
- Histologically confirmed Advanced Unresectable Esophageal Squamous Cell Carcinomas,unresectable of clinical stage II-IVa patients (include unresectable,or surgical contraindication or refuse surgery)(According to AJCC 8th Edition stage , Pre-treatment clinical stage cT1N2-3M0,cT2-4bN0-3M0.
- At least 1 measurable target lesion and/or unmeasurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).
Key exclusion criteria (5 listed)
- Patients who have a history of esophageal cancer surgery.
- Previous history of fistula caused by primary tumor infiltration.
- a high risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation.
- Subjects with poor nutritional status and weight loss of ≥ 10% in the first 2 months of screening have no significant improvement after nursing intervention.
- Major surgery or serious trauma within 4 weeks before the first use of the study drug.
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 |
|---|---|---|
| QL1706Also: Radiation, Taxol, CisplatinQL1706 is a humanized anti-PD1 IgG4 and anti-CTLA-4 IgG4 antibody. | Drug | QL1706 plus Chemotherapy and Radiotherapy |
Primary outcome
PFS assessed by investigators
Time frame: Up to approximately 2 years.
Progression-free survival assessed by investigators
4 secondary outcomes
OS
Time frame: 1year and 3years
ORR
Time frame: Up to approximately 2 years
DoR
Time frame: Up to approximately 2 years
The rates and severity of Adverse Events, Serious Adverse Events
Time frame: Through study completion, up to approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Derived from this study: PubMed 41623855Zhang W, Zhang T, Chen X, Li J, Gao L, Jiang S, Wang Y, Zheng Z, Dong J, Li Z, Zhao G, Cao F, Bai N, Wang P, Yan C, Pang Q. Iparomlimab and tuvonralimab (QL1706) combined definitive chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma (QL1706-IIT-02): a single arm, phase 2 trial. EClinicalMedicine. 2026 Jan 21;92:103758. doi: 10.1016/j.eclinm.2026.103758. eCollection 2026 Feb.
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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. This study is not recruiting at the moment.
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 QL1706 in people with Esophageal Squamous Cell Carcinoma, run by Tianjin Medical University Cancer Institute and 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qingsong Pang (0862223340123 ext. 1121, pangqingsong2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS assessed by investigators (time frame: Up to approximately 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 NCT05490719, which also lists 1 linked publication.
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 21 May 2024.