Clinical trial · Interventional
Neoadjuvant Immunotherapy Combined With Chemotherapy Sequenced With Endoscopic Resection for Esophageal Cancer (Endosurgery-02)
Safety and Feasibility of Neoadjuvant Immunotherapy Combined With Chemotherapy Sequenced With Endoscopic Resection for Esophageal Cancer (Endosurgery-02)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This single-center, prospective, single-arm study will evaluate whether giving neoadjuvant chemoimmunotherapy can safely shrink esophageal cancer and allow organ-preserving endoscopic removal in selected patients. Adults with esophageal cancer will receive at least two 3-week cycles of a PD-1 inhibitor (tislelizumab 200 mg on Day 1) plus carboplatin (AUC 3-5, Day 1) and nab-paclitaxel (≤260 mg/m², Day 1). During treatment, routine safety tests are performed. About 3-4 weeks after completing at least two cycles, participants undergo clinical reassessment with examinations and imaging (such as endoscopy, endoscopic ultrasound, PET/CT or CT of the neck, chest, and upper abdomen) to evaluate tumor shrinkage and possible spread. Tumor response is assessed using RECIST 1.1. If a clinical complete response is achieved without obvious nodal disease, endoscopic resection may be performed to preserve the esophagus; otherwise, patients may proceed to surgery or concurrent chemoradiation per clinical judgment. The study focuses on feasibility and safety of this organ-preserving approach and describes tumor responses after therapy. Potential benefits include tumor shrinkage and avoiding major surgery in selected cases; risks include side effects of standard chemotherapy/immunotherapy and procedure-related discomforts from biopsies or endoscopic treatments.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma (ESCC) | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Concurrent chemoradiation | Radiation | — | UNRESOLVED |
| Endoscopic resection | Procedure | — | UNRESOLVED |
| Esophagectomy | Procedure | — | UNRESOLVED |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant Tislelizumab + Carboplatin + Nab-Paclitaxel
- description
- 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.
- interventionNames
- Drug: Tislelizumab
- Drug: Carboplatin
- Drug: Nab-paclitaxel
- Procedure: Endoscopic resection
- Procedure: Esophagectomy
- Radiation: Concurrent chemoradiation
Primary outcomes (4)
- measure
- Organ preservation rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Cohort A - Potentially resectable ESCC: Inclusion Criteria: 1. Age range: 18-80 years old; 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. Exclusion Criteria: 1. Patients with potential tracheoesophageal fistula or aortoesophageal fistula; 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: Inclusion Criteria: 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: 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.
References
Publications (16)
- RESULTWu 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. PMID 37433041
- RESULTAjani JA, D'Amico TA, Bentrem DJ, Chao J, Corvera C, Das P, Denlinger CS, Enzinger PC, Fanta P, Farjah F, Gerdes H, Gibson M, Glasgow RE, Hayman JA, Hochwald S, Hofstetter WL, Ilson DH, Jaroszewski D, Johung KL, Keswani RN, Kleinberg LR, Leong S, Ly QP, Matkowskyj KA, McNamara M, Mulcahy MF, Paluri RK, Park H, Perry KA, Pimiento J, Poultsides GA, Roses R, Strong VE, Wiesner G, Willett CG, Wright CD, McMillian NR, Pluchino LA. Esophageal and Esophagogastric Junction Cancers, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019 Jul 1;17(7):855-883. doi: 10.6004/jnccn.2019.0033. PMID 31319389
- RESULTNCT02551458
- RESULTNoordman BJ, Wijnhoven BPL, Lagarde SM, Boonstra JJ, Coene PPLO, Dekker JWT, Doukas M, van der Gaast A, Heisterkamp J, Kouwenhoven EA, Nieuwenhuijzen GAP, Pierie JEN, Rosman C, van Sandick JW, van der Sangen MJC, Sosef MN, Spaander MCW, Valkema R, van der Zaag ES, Steyerberg EW, van Lanschot JJB; SANO-study group. Neoadjuvant chemoradiotherapy plus surgery versus active surveillance for oesophageal cancer: a stepped-wedge cluster randomised trial. BMC Cancer. 2018 Feb 6;18(1):142. doi: 10.1186/s12885-018-4034-1. PMID 29409469
- RESULTZhang X, Eyck BM, Yang Y, Liu J, Chao YK, Hou MM, Hung TM, Pang Q, Yu ZT, Jiang H, Law S, Wong I, Lam KO, van der Wilk BJ, van der Gaast A, Spaander MCW, Valkema R, Lagarde SM, Wijnhoven BPL, van Lanschot JJB, Li Z. Accuracy of detecting residual disease after neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma (preSINO trial): a prospective multicenter diagnostic cohort study. BMC Cancer. 2020 Mar 6;20(1):194. doi: 10.1186/s12885-020-6669-y. PMID 32143580