ESCCPhase 2NCT07524374
SHR-1701 in Combination With Irinotecan Liposome (II) for Second-line Treatment of ESCC After Immunotherapy
A Phase 2 study testing SHR-1701+ liposomal irinotecan (II) in people with ESCC, run by Zhigang Li at 1 site in China.
Trial summary
This study is a single-arm, exploratory clinical trial aimed at evaluating the efficacy and safety of SHR-1701 in combination with liposomal irinotecan (II) in patients with esophageal squamous cell carcinoma who have received prior immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESCC
- What is being tested?
- SHR-1701+ liposomal irinotecan (II)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2026to 30 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent, voluntarily participating in this study;
- Histopathologically or cytologically confirmed esophageal squamous cell carcinoma;
- Prior treatment with immunotherapy;
- At least one measurable lesion as assessed by RECIST version 1.1;
- Age ≥ 18 years, male or female;
- ECOG performance status of 0 or 1;
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- Life expectancy > 3 months;
- Adequate organ function:
- Hematology: Neutrophils ≥ 1.5 × 10^9/L, Hemoglobin ≥ 9 g/dL, Platelets ≥ 100 × 10^9/L.
- Hepatic function: Bilirubin ≤ 1.5 × the upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin ≤ 3 × ULN are eligible); AST and ALT ≤ 2.5 × ULN (if liver metastases are present, AST/ALT ≤ 5 × ULN); Alkaline phosphatase ≤ 3 × ULN (if liver or bone metastases are present, ALP ≤ 5 × ULN); Albumin ≥ 3 g/dL.
- Renal function: Serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate by Cockcroft-Gault: Creatinine clearance ≥ 60 mL/min.
- Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Female patients of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose, must not be breastfeeding, and must agree to use effective contraception for 6 months after the last dose; for male patients with a partner of childbearing potential, effective contraception must be used for 3 months after the last dose; sperm donation is not permitted during the study;
- Patients are well compliant and agree to cooperate with follow-up.
Who cannot join
- 1. Active or untreated central nervous system (CNS) metastases (e.g., brain or leptomeningeal metastases) as determined by CT or magnetic resonance imaging (MRI) assessment during screening.
- 2. Uncontrolled tumor-related pain. 3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently); patients with an indwelling catheter (e.g., PleurX®) are permitted.
- 4. History of a malignancy other than esophageal cancer within 5 years prior to enrollment, except for malignancies with a negligible risk of metastasis or death (e.g., expected 5-year overall survival > 90%) and those that are expected to be cured after treatment.
- 5. History of allergy to monoclonal antibodies, liposomal products, or irinotecan.
- 6. Prior or current receipt of any of the following therapies:
- Use of immunosuppressive medications or systemic corticosteroid therapy for immunosuppressive purposes (dose > 10 mg/day prednisone or equivalent) within 2 weeks prior to the first dose of study drug; inhaled or topical steroids and adrenal corticosteroid replacement at doses > 10 mg/day prednisone or equivalent are permitted in the absence of active autoimmune disease.
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- Receipt of a live attenuated vaccine within 4 weeks prior to the first dose of study drug.
- Major surgery or significant traumatic injury within 4 weeks prior to the first dose of study drug.
- 7. Any active autoimmune disease or a history of autoimmune disease. 8. History of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
- 9. Presence of poorly controlled cardiac clinical symptoms or diseases. 10. Occurrence of a severe infection within 4 weeks prior to the first dose of study drug.
- 11. Active pulmonary tuberculosis infection as identified by medical history or CT examination.
- 12. Active hepatitis B (HBV DNA ≥ 200 IU/mL or ≥ 1000 copies/mL or ≥ the upper limit of normal), or hepatitis C (positive hepatitis C antibody and HCV RNA above the lower limit of quantification of the assay).
- 13. Pregnant or breastfeeding women. 14. Any other condition judged by the investigator that could lead to forced discontinuation from the study, such as other serious illnesses (including mental illnesses) requiring concomitant treatment, alcoholism, drug abuse, family or social factors, or factors that could affect patient safety or compliance.
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
Shanghai Chest Hospital
Shanghai
Haoran Zhai, 021-34206890, haoran.zhai.123@hotmail.com
Zhigang Li, MD
About this study
Official title: The Efficacy, Safety and Feasibility of SHR-1701 in Combination With Irinotecan Liposome (II) for Second-line Treatment of Esophageal Squamous Cell Carcinoma After Immunotherapy
This study is a single-arm, exploratory clinical trial aimed at evaluating the efficacy and safety of SHR-1701 in combination with liposomal irinotecan (II) in patients with esophageal squamous cell carcinoma who have received prior immunotherapy. Eligible patients with esophageal cancer will be treated with SHR-1701 in combination with liposomal irinotecan (II).
- Conditions
- ESCC
- Being tested
- SHR-1701+ liposomal irinotecan (II)
- Keywords
- ESCC, SHR-1701, Retlirafusp alfa, Liposomal Irinotecan (II)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1701+ liposomal irinotecan (II)Drug
SHR-1701 in combination with Irinotecan Liposome (II) is administered on Day 1 of each 3-week treatment cycle until disease progression, intolerable toxicity, withdrawal of consent, or a decision by the investigator to discontinue treatment, or until the maximum treatment duration of 2 years has been reached, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | SHR-1701+ liposomal irinotecan (II) Receives: Drug: SHR-1701+ liposomal irinotecan (II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective response rate (ORR) defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR).
Measured: through study completion, an average of 12 weeks
Secondary outcomes (4)
Disease Control Rate
Disease Control Rate (DCR) defined as the proportion of patients whose best overall response is CR, PR, or SD.
Measured: through study completion, an average of 12 weeks
Progression-Free Survival
Progression-Free Survival defined as the time from the first dose to the first documented disease progression as assessed by the investigator per RECIST version 1.1, or the time from enrollment to death from any cause, whichever occurs first.
Measured: through study completion, an average of 6 months
Oearall survival
Overall Survival (OS) Defined as the time from the first dose to death from any cause.
Measured: through study completion, an average of 12 months
Safty
Adverse Events (AEs): Incidence and severity (including whether they are serious adverse events or immune-related adverse events), with severity graded according to NCI-CTCAE version 6.0;
Measured: Documented from the time of signing the informed consent form until the end of the safety follow-up period (Day 90 after the last dose) or the initiation of a new anti-cancer therapy, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start15 Mar 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESCCStudies 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhigang Li
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor-investigator, Zhigang Li, Shanghai Chest Hospital
- Investigators
- Zhigang Li, MD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524374
- Sponsor's protocol ID
- IS26016
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 13 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy, Safety and Feasibility of SHR-1701 in Combination With Irinotecan Liposome (II) for Second-line Treatment of Esophageal Squamous Cell Carcinoma After Immunotherapy
- ClinicalTrials.gov ID
- NCT07524374
- Acronym / sponsor ID
- IS26016
- Conditions
- ESCC
- Keywords
- ESCC, SHR-1701, Retlirafusp alfa, Liposomal Irinotecan (II)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Zhigang LiUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 13 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.
This study is a single-arm, exploratory clinical trial aimed at evaluating the efficacy and safety of SHR-1701 in combination with liposomal irinotecan (II) in patients with esophageal squamous cell carcinoma who have received prior immunotherapy. Eligible patients with esophageal cancer will be treated with SHR-1701 in combination with liposomal irinotecan (II).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: SHR-1701+ liposomal irinotecan (II)SHR-1701+ liposomal irinotecan (II) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed written informed consent, voluntarily participating in this study;
- Histopathologically or cytologically confirmed esophageal squamous cell carcinoma;
- Prior treatment with immunotherapy;
- At least one measurable lesion as assessed by RECIST version 1.1;
- Age ≥ 18 years, male or female;
Key exclusion criteria (13 listed)
- 1. Active or untreated central nervous system (CNS) metastases (e.g., brain or leptomeningeal metastases) as determined by CT or magnetic resonance imaging (MRI) assessment during screening.
- 2. Uncontrolled tumor-related pain. 3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently); patients with an indwelling catheter (e.g., PleurX®) are permitted.
- 4. History of a malignancy other than esophageal cancer within 5 years prior to enrollment, except for malignancies with a negligible risk of metastasis or death (e.g., expected 5-year overall survival > 90%) and those that are expected to be cured after treatment.
- 5. History of allergy to monoclonal antibodies, liposomal products, or irinotecan.
- 7. Any active autoimmune disease or a history of autoimmune disease. 8. History of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
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 |
|---|---|---|
| SHR-1701+ liposomal irinotecan (II)SHR-1701 in combination with Irinotecan Liposome (II) is administered on Day 1 of each 3-week treatment cycle until disease progression, intolerable toxicity, withdrawal of consent, or a decision by the investigator to discontinue treatment, or until the maximum treatment duration of 2 years has been reached, whichever occurs first. | Drug | treatment group |
Primary outcome
Objective Response Rate
Time frame: through study completion, an average of 12 weeks
Objective response rate (ORR) defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR).
4 secondary outcomes
Disease Control Rate
Time frame: through study completion, an average of 12 weeks
Progression-Free Survival
Time frame: through study completion, an average of 6 months
Oearall survival
Time frame: through study completion, an average of 12 months
Safty
Time frame: Documented from the time of signing the informed consent form until the end of the safety follow-up period (Day 90 after the last dose) or the initiation of a new anti-cancer therapy, whichever occurs first.
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 13 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.
Zhigang Li, MD principal investigator
Shanghai Chest Hospital
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 SHR-1701+ liposomal irinotecan (II) in people with ESCC, run by Zhigang Li 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 14 inclusion and 13 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 13 Apr 2026. 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 Haoran Zhai (021-34206890, haoran.zhai.123@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: through study completion, an average of 12 weeks). 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 13 Apr 2026.