Trials Sponsors Conditions Drugs Pricing

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Keywords

neoadjuvant, chemoimmunotherapy, tislelizumab, carboplatin, nab-paclitaxel, endoscopic submucosal dissection/ESD

Outcome Measures

Primary Outcomes (4)

Organ preservation rate
Proportion of enrolled participants who achieve esophageal organ preservation after neoadjuvant therapy, defined as: (1) clinical complete response at reassessment \~3-4 weeks after ≥2 cycles; (2) endoscopic tumor resection (e.g., ESD) performed 3-6 weeks after therapy with curative intent and negative margins (R0) when resection is undertaken; and (3) no planned or salvage esophagectomy through 12 months. Participants who require esophagectomy, have persistent/progressive disease precluding endoscopic therapy, or die before assessment are counted as non-preserved.
Up to 12 months after completion of neoadjuvant therapy
Overall safety: incidence of Grade ≥3 adverse events related to drug, endoscopic procedures, surgery, or radiation
Proportion of participants with at least one Grade ≥3 adverse event from any study-specified modality: 1. Drug-related treatment-related adverse events (TRAEs) graded by CTCAE v5.0 . 2. Endoscopic complications when resection is performed (clinically significant bleeding requiring intervention, perforation, or stricture requiring dilation/stenting), adjudicated per institutional/ASGE criteria; 3. Surgical morbidity after esophagectomy (Clavien-Dindo grade ≥III within 90 days of surgery); 4. Radiation toxicities among those receiving concurrent chemoradiation (CTCAE v5.0 grade ≥3). Serious adverse events (SAEs) (death, life-threatening event, inpatient hospitalization/prolongation, disability, or other medically important event) and 30-/90-day all-cause mortality are captured; if multiple events occur, the worst grade counts for this composite endpoint
Adverse event was assessed peri-procedural of drug-using, endoscopic procedures, surgery, or radiation up to 30 days
Two-year overall survival rate
Proportion of participants alive 24 months after index date regardless of cause of death (all-cause mortality). The index date is Day 1 of the first neoadjuvant cycle. Survival status is ascertained from clinic visits, hospital records, and scheduled follow-up contacts. The OS rate at 24 months will be estimated using the Kaplan-Meier method with 95% confidence interval. Participants alive at last contact before 24 months are censored at that date; deaths at any time up to 24 months count as events, including those occurring after endoscopic resection, esophagectomy, or chemoradiation.

Study Arms (1)

Neoadjuvant Tislelizumab + Carboplatin + Nab-Paclitaxel

EXPERIMENTAL

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.

Drug: TislelizumabDrug: CarboplatinDrug: Nab-paclitaxelProcedure: Endoscopic resectionProcedure: EsophagectomyRadiation: Concurrent chemoradiation

Interventions

Nab-paclitaxelDRUG

≤260 mg/m² IV on Day 1, Q3W (\~30-min infusion) for ≥2 cycles, combined with tislelizumab and carboplatin in the neoadjuvant regimen.

Neoadjuvant Tislelizumab + Carboplatin + Nab-Paclitaxel

Endoscopic resectionPROCEDURE

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.

Neoadjuvant Tislelizumab + Carboplatin + Nab-Paclitaxel

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age range: 18-80 years old;
Patients diagnosed with esophageal squamous cell carcinoma (ESCC) through histopathological examination of biopsy tissues from the primary tumor;

Sponsors & Collaborators

Shanghai Zhongshan Hospitallead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Li-Yun Ma, MDCONTACT+86 13162909612 maly14@fudan.edu.cn

Related Publications (16)

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.
PMID: 37433041RESULT
Ajani 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

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

tislelizumabCarboplatin130-nm albumin-bound paclitaxelEndoscopic Mucosal ResectionEsophagectomy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal Neoplasms

Central Study Contacts

Li-Yun Ma, MD

CONTACT

+86 13162909612 maly14@fudan.edu.cn

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 25, 2025

First Posted

January 5, 2026

Study Start

July 15, 2025

Actual (reported)

Primary Completion

September 30, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

You may not qualify if:

Patients with potential tracheoesophageal fistula or aortoesophageal fistula;
Patients with severe malnutrition or requiring tube feeding;
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);
Patients with active autoimmune diseases or a history of autoimmune diseases or symptoms that require systemic corticosteroid treatment or anti-autoimmune drug therapy;
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;
Patients with active infections requiring systemic treatment within 7 days before the first neoadjuvant therapy in this study;
Patients with a history of allogeneic organ or stem cell transplantation;
Patients with allergies to drugs or related components involved in this study;
Patients who are currently participating in any other clinical study.
Cohort B - Surgery-contraindicated ESCC:
Individuals aged above 18 years;
Patients diagnosed with esophageal squamous cell carcinoma through histopathological examination of biopsy tissues from the primary tumor;
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;
Patients who have not undergone any antitumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, and targeted therapy;
Female patients of reproductive age should have a negative pregnancy test and be willing to adopt effective contraceptive measures during the study period;
+3 more criteria

Neoadjuvant Immunotherapy Combined With Chemotherapy Sequenced With Endoscopic Resection for Esophageal Cancer (Endosurgery-02)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (1)

Neoadjuvant Tislelizumab + Carboplatin + Nab-Paclitaxel

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (16)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (1)

Neoadjuvant Tislelizumab + Carboplatin + Nab-Paclitaxel

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (16)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations