Borderline Resectable CarcinomaPhase 2ILDR-03NCT07339488
Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable/Unresectable Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Intestinal Low Dose Radiotherapy-1Gy, PD-1/PD-L1 inhibitors and Chemotherapy in people with Borderline Resectable Carcinoma and Unresectable Cancer, run by Chuangzhen Chen at 1 site in China.
Trial summary
Esophageal cancer (EC) ranks among the leading malignant gastrointestinal tumors globally in terms of both incidence and mortality. Cases of EC in China account for over 50% of the global total, with squamous cell carcinoma being the primary pathological type. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Borderline Resectable Carcinoma, Unresectable Cancer, Esophageal Squamous Cell Carcinoma (ESCC)
- What is being tested?
- Intestinal Low Dose Radiotherapy-1Gy, PD-1/PD-L1 inhibitors and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2025to 30 Oct 2029
- Phase
- Phase 2
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
- Patients voluntarily enroll in this study, sign an informed consent form, and demonstrate good compliance.
- Age ≥18 years and ≤75 years; both sexes are eligible.
- ECOG performance status score of 0-1.
- Pathologically confirmed esophageal squamous cell carcinoma (ESCC) prior to surgery.
- Thoracic esophageal cancer.
- Unresectable lesions, defined as: T4 stage; Borderline resectable T3 disease, in which imaging cannot exclude invasion of adjacent organs or structures, such as the trachea, bronchi, or aorta; T3 disease with supraclavicular lymph node metastasis; or clinically confirmed unresectable disease by the surgeon.
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- No prior history of anti-tumor treatment, including chemotherapy, hormonal therapy, radiotherapy, or immunotherapy.
- Baseline laboratory requirements (within 7 days prior to enrollment):
- Hematology:
- Hb≥90 g/L (no transfusion within 14 days)
- NEUT ≥1.5×10⁹/L
- PLT ≥100×10⁹/L
- WBC≥3×10⁹/L
- Biochemistry:
- ALT and AST≤2.5×ULN
- TBIL≤1.5×ULN
- SCr≤1.5×ULN; or CrCl≥60 mL/min Coagulation: APTT, INR, and PT≤1.5×ULN Thyroid function: TSH≤ULN (if abnormal, FT3/FT4 levels should also be considered; eligible if FT3/FT4 are normal) Echocardiography: LVEF≥50%
- Female subjects need to agree to use contraception during the study and for 6 months post-study; serum pregnancy test negative within 7 days prior to enrollment; non-lactating. Male subjects must agree to use contraception during the study and for 6 months post-study.
- No psychological, familial, social, or geographical factors that may impair protocol adherence.
- Other parameters meet general clinical trial enrollment criteria.
- The subject or authorized representative has read, fully understands the patient information sheet, and signed the informed consent form.
Who cannot join
- Patients with distant metastases other than supraclavicular lymph node metastases.
- Presence or high risk of esophageal perforation.
- Patients with contraindications to radiotherapy or immune checkpoint inhibitor (ICI) therapy.
- Subjects with active, uncontrolled systemic bacterial, viral, or fungal infections despite optimal treatment.
- Respiratory depression, airway obstruction, or tissue hypoxia.
- Severe cardiac disease (i.e., NYHA functional class II or higher).
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- Markedly abnormal liver or kidney function (i.e., indicators >3 times the upper limit of normal).
- Active hepatitis B, hepatitis C, HIV, or syphilis.
- Active brain disease or central nervous system/meningeal metastases with significant symptoms, or impaired decision-making capacity.
- Hypersensitivity to drugs included in the trial.
- Drug and/or alcohol abuse.
- Pregnant or lactating women.
- Concurrent participation in another therapeutic clinical trial.
- Major surgical procedure within 30 days prior to enrollment.
- Use of antibiotics, antifungals, antivirals, or antiparasitics within 4 weeks prior to registration.
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
Cancer Hospital, Shantou University Medical College
Shantou, Guangdong, 515031
Chuangzhen Chen, +86 13923995569, czchen2@stu.edu.cn
About this study
Official title: Efficacy and Safety of Combining Intestinal Low Dose Radiotherapy Plus Tislelizumab and Chemotherapy for Conversion of Borderline Resectable/Unresectable Esophageal Squamous Cell Carcinoma
Esophageal cancer (EC) ranks among the leading malignant gastrointestinal tumors globally in terms of both incidence and mortality. Cases of EC in China account for over 50% of the global total, with squamous cell carcinoma being the primary pathological type. Locally advanced EC (LAEC), particularly cases where radical surgical resection is not feasible, exhibits high recurrence rates and low 5-year survival rates. However, studies have shown that patients with LAEC who undergo comprehensive treatment followed by surgery experience significantly prolonged survival and improved quality of life compared to those who do not receive surgical intervention.
Current conversion treatment regimens under investigation include: chemotherapy alone, chemoradiotherapy, immunotherapy combined with chemotherapy, and immunotherapy combined with chemoradiotherapy-each of these approaches has distinct advantages and limitations. Immunochemotherapy has emerged as a current research focus: it not only demonstrates significantly superior efficacy compared to chemotherapy alone but also exhibits lower cumulative toxicity than radiotherapy-combined conversion regimens, resulting in a more favorable overall benefit-risk ratio. As such, it represents the most promising conversion treatment strategy.
Read more
Retrospective and prospective clinical studies have shown that low-dose radiotherapy targeting the small intestine can enhance the anti-tumor response of immune checkpoint inhibitors (ICIs) in patients with advanced solid tumor, prolong their overall survival, and increase the incidence of the abscopal effect. Further mechanistic investigations have revealed that intestinal low-dose radiotherapy (ILDR) may augment the immune cancerous lethality by modulating the gut microbiota and their metabolic profiles.
Based on the findings from these preliminary studies, the current research plans to conduct a prospective phase II single-arm clinical trial to investigate the efficacy and safety of ILDR combined with immunochemotherapy as conversion therapy in patients with borderline resectable or unresectable esophageal squamous cell carcinoma (BR/UR ESCC). This research plans to enroll at least 39 evaluable cases or a total of 39 cases in two seperated stages, focusing on patients with thoracic BR/UR ESCC. Patients will receive a single fraction of ILDR with a mean dose of 1 Gy, concurrently with 3 cycles of albumin-bound paclitaxel (260 mg/m² on day 1), cisplatin (75 mg/m² on day 1), and tislelizumab (200 mg on day 1). The efficacy and safety of the treatment will be evaluated throughout the study.
- Conditions
- Borderline Resectable Carcinoma, Unresectable Cancer, Esophageal Squamous Cell Carcinoma (ESCC), Immune Checkpoint Inhibitor, Chemotherapy, Radiotherapy
- Being tested
- Intestinal Low Dose Radiotherapy-1Gy, PD-1/PD-L1 inhibitors, Chemotherapy, Surgery
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal Low Dose Radiotherapy-1GyRadiation
1Gy ILDR will be administered to patients in a single fraction. The radiation treatment volume composes both the jejunum and ileum.
PD-1/PD-L1 inhibitorsDrug
3 cycles of tislelizumab（200 mg D1 q3w）
ChemotherapyDrug
3 cycles of albumin-bound paclitaxel（260 mg/m2 D1 q3w）+ cisplatin（75 mg/m2 D1 q3w）
SurgeryProcedure or surgery
McKeown esophagectomy or laparoscopic-assisted McKeown esophagectomy is recommended, with either two-and-a-half-field lymphadenectomy or three-field lymph node dissection.
| Study group | Role | What they receive |
|---|---|---|
| ILDR plus immunochemotherapy plus surgery | Experimental | 1Gy/1F ILDR + albumin-bound paclitaxel (3 cycles of 260 mg/m² on day 1), cisplatin (3 cycles of 75 mg/m² on day 1), and tislelizumab (3 cycles of 200 mg on day 1) + surgery Receives: Radiation: Intestinal Low Dose Radiotherapy-1Gy; Drug: PD-1/PD-L1 inhibitors; Drug: Chemotherapy; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Year Progression-Free Survival Rate (1y-PFSR)
The 1y-PFSR is defined as the proportion of patients who remain alive without documented cancer progression 1 year after the initiation of treatment.
Measured: Up to 12 months after the initiation of treatment.
Secondary outcomes (8)
Pathological Complete Response (pCR) Rate
The proportion of patients who, following conversion therapy, exhibit no residual invasive cancer cells in either the primary tumor site or regional lymph nodes upon pathological evaluation of surgical resection specimens, expressed as a percentage of the total treated population.
Measured: From postoperative day 0 up to 15 weeks postoperatively.
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) (sustained ≥4 weeks) per RECIST v1.1 and iRECIST criteria.
Measured: Baseline, every 6 weeks during conversion therapy, postoperation, every 4 months following the first postoperative assessment with a maximum duration of 12 months.
Major Pathological Response (MPR) Rate
MPR is defined as the proportion of patients with ≤10% residual viable tumor cells in surgical specimens following treatment. Pathological evaluation requires standardized sampling and separate assessment of lymph node metastases.
Measured: From postoperative day 0 up to 15 weeks postoperatively.
Disease Control Rate (DCR)
DCR is defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) post-treatment, as measured by RECIST 1.1 and iRECIST criteria.
Measured: Baseline, every 6 weeks during conversion therapy, postoperation, every 4 months following the first postoperative assessment with a maximum duration of 12 months.
Adverse Event Incidence Rate
The proportion of patients experiencing adverse events of any grade (graded according to CTCAE 6.0, Common Terminology Criteria for Adverse Events, grades 1-5) during treatment.
Measured: Up to 12 months after surgery.
1-Year Overall Survival Rate (1y-OSR)
The 1y-OSR is defined as the proportion of patients who have not experienced all-cause death at 12 months following the initiation of treatment.
Measured: Up to 12 months after the initiation of treatment.
Surgical Conversion Rate
Defined as the proportion of initially unresectable patients who are converted to resectable status following treatment.
Measured: Up to 12 months after surgery.
R0 Resection Rate
Defined as the proportion of radical surgeries achieving microscopically negative margins (margin ≥1 mm).
Measured: From postoperative day 0 up to 15 weeks postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start5 Dec 2025
- Primary completion30 Oct 2029 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Resectable 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuangzhen Chen
- Sponsor type
- University, hospital or other
- Collaborators
- BeOne Medicines
- Responsible party
- Sponsor-investigator, Chuangzhen Chen, Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339488
- Sponsor's protocol ID
- SUMC-ILDR03
- Acronym
- ILDR-03
- Status last verified
- Sep 2026
- First submitted
- 1 Dec 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No