Neoadjuvant Immunotherapy Combined With Chemotherapy Sequenced With Endoscopic Resection for Esophageal Cancer (Endosurgery-02)
NCT ID: NCT07317609
Last Updated: 2026-01-05
Study Results
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Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2025-07-15
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Neoadjuvant Tislelizumab + Carboplatin + Nab-Paclitaxel
Participants receive neoadjuvant chemoimmunotherapy for at least two 3-week cycles: tislelizumab 200 mg IV on Day 1 (Q3W) plus carboplatin AUC 3-5 IV on Day 1 (Q3W) and nab-paclitaxel ≤260 mg/m² IV on Day 1 (Q3W; \~30-minute infusion). Safety is assessed during treatment. About 3-4 weeks after completing ≥2 cycles, participants undergo clinical reassessment (physical exam, labs, and imaging including endoscopy/EUS and PET/CT or CT of neck, chest, and upper abdomen) and tumor response is evaluated by RECIST 1.1. If clinical complete response (cCR) is achieved without obvious nodal disease, endoscopic resection is performed 3-6 weeks after neoadjuvant therapy; otherwise, patients proceed to standard esophagectomy or concurrent chemoradiation per investigator judgment.
Tislelizumab
Fixed-dose anti-PD-1 monoclonal antibody 200 mg IV on Day 1 of each 3-week cycle (Q3W) as neoadjuvant therapy, administered before any local resection. Given for ≥2 cycles unless contraindicated. Used in combination with carboplatin and nab-paclitaxel in a single-arm regimen; no placebo or comparator.
Carboplatin
Intervention Description: AUC 3-5 IV on Day 1, Q3W, for ≥2 cycles in combination with tislelizumab and nab-paclitaxel as neoadjuvant therapy.
Nab-paclitaxel
≤260 mg/m² IV on Day 1, Q3W (\~30-min infusion) for ≥2 cycles, combined with tislelizumab and carboplatin in the neoadjuvant regimen.
Endoscopic resection
Endoscopic resection (e.g., ESD/EFTR) performed 3-6 weeks after completing ≥2 neoadjuvant cycles only if clinical complete response (cCR) is achieved without clear nodal metastasis, based on endoscopy/EUS and imaging. Technique follows institutional standards with curative intent and margin assessment.
Esophagectomy
Standard surgical esophagectomy (McKeown/Ivor-Lewis procedures) for participants not meeting cCR criteria or deemed unsuitable for endoscopic resection after reassessment. Conducted per institutional standard of care, with lymphadenectomy as appropriate.
Concurrent chemoradiation
Concurrent chemoradiation per institutional standard for participants not eligible for endoscopic resection and managed non-surgically after reassessment. External-beam radiation delivered with concurrent platinum-taxane chemotherapy as clinically indicated; specific dose/fractionation per treating radiation oncologist.
Interventions
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Tislelizumab
Fixed-dose anti-PD-1 monoclonal antibody 200 mg IV on Day 1 of each 3-week cycle (Q3W) as neoadjuvant therapy, administered before any local resection. Given for ≥2 cycles unless contraindicated. Used in combination with carboplatin and nab-paclitaxel in a single-arm regimen; no placebo or comparator.
Carboplatin
Intervention Description: AUC 3-5 IV on Day 1, Q3W, for ≥2 cycles in combination with tislelizumab and nab-paclitaxel as neoadjuvant therapy.
Nab-paclitaxel
≤260 mg/m² IV on Day 1, Q3W (\~30-min infusion) for ≥2 cycles, combined with tislelizumab and carboplatin in the neoadjuvant regimen.
Endoscopic resection
Endoscopic resection (e.g., ESD/EFTR) performed 3-6 weeks after completing ≥2 neoadjuvant cycles only if clinical complete response (cCR) is achieved without clear nodal metastasis, based on endoscopy/EUS and imaging. Technique follows institutional standards with curative intent and margin assessment.
Esophagectomy
Standard surgical esophagectomy (McKeown/Ivor-Lewis procedures) for participants not meeting cCR criteria or deemed unsuitable for endoscopic resection after reassessment. Conducted per institutional standard of care, with lymphadenectomy as appropriate.
Concurrent chemoradiation
Concurrent chemoradiation per institutional standard for participants not eligible for endoscopic resection and managed non-surgically after reassessment. External-beam radiation delivered with concurrent platinum-taxane chemotherapy as clinically indicated; specific dose/fractionation per treating radiation oncologist.
Eligibility Criteria
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Inclusion Criteria
2. Patients diagnosed with esophageal squamous cell carcinoma (ESCC) through histopathological examination of biopsy tissues from the primary tumor;
3. Patients with potentially resectable esophageal cancer confirmed by imaging and endoscopic examinations (T1b-3, N0, M0, with a tumor size not exceeding 5 cm and occupying less than 2/3 of the luminal circumference); Patients who have not received any antitumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, and targeted therapy;
4. Patients with a preoperative Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
5. Patients with a preoperative American Society of Anesthesiologists (ASA) physical status classification of I-III;
6. Female patients of reproductive age should have a negative pregnancy test and be willing to use effective contraceptive methods during the study period;
7. Patients who have signed the informed consent form.
1. Individuals aged above 18 years;
2. Patients diagnosed with esophageal squamous cell carcinoma through histopathological examination of biopsy tissues from the primary tumor;
3. Patients with esophageal cancer deemed as surgically contraindicated (including those with cervical esophageal cancer, surgical contraindications, those who refuse surgery, or those considered high-risk for esophagectomy, defined as having at least one of the following characteristics: (1) age over 75 years, (2) Charlson comorbidity index \>= 2, (3) presence of moderate lung dysfunction, (4) malnutrition (with a body mass index below 18 kg/m\^2)), with a clinical staging of cT1b-3N0M0, a tumor size not exceeding 5 cm, and occupying less than 2/3 of the luminal circumference;
4. Patients who have not undergone any antitumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, and targeted therapy;
5. Female patients of reproductive age should have a negative pregnancy test and be willing to adopt effective contraceptive measures during the study period;
6. Patients who have signed the informed consent form.
Exclusion Criteria
2. Patients with severe malnutrition or requiring tube feeding;
3. Patients with other malignancies that have not been cured within the past 2 years (except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix);
4. Patients with active autoimmune diseases or a history of autoimmune diseases or symptoms that require systemic corticosteroid treatment or anti-autoimmune drug therapy;
5. Immunocompromised patients, or patients who are still receiving systemic steroids (prednisone \> 10 mg/day or equivalent) or other forms of immunosuppressive therapy within 7 days before the first dose of neoadjuvant therapy in this study;
6. Patients with active infections requiring systemic treatment within 7 days before the first neoadjuvant therapy in this study;
7. Patients with a history of allogeneic organ or stem cell transplantation;
8. Patients with allergies to drugs or related components involved in this study;
9. Patients who are currently participating in any other clinical study.
Cohort B - Surgery-contraindicated ESCC:
1. Patients with allergies to the drugs or related components involved in this study;
2. Patients who are currently participating in any other clinical study.
18 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Locations
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Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Wu H, Leng X, Liu Q, Mao T, Jiang T, Liu Y, Li F, Cao C, Fan J, Chen L, Chen Y, Yao Q, Lu S, Liang R, Hu L, Liu M, Wan Y, Li Z, Peng J, Luo Q, Zhou H, Yin J, Xu K, Lan M, Peng X, Lan H, Li G, Han Y, Zhang X, Xiao ZJ, Lang J, Wang G, Xu C. Intratumoral Microbiota Composition Regulates Chemoimmunotherapy Response in Esophageal Squamous Cell Carcinoma. Cancer Res. 2023 Sep 15;83(18):3131-3144. doi: 10.1158/0008-5472.CAN-22-2593.
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NCT02551458
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Other Identifiers
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ShanghaiZhongshanEndosurgery02
Identifier Type: -
Identifier Source: org_study_id
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