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Esophageal Squamous Cell Carcinoma (ESCC)Phase 1Endosurgery-02NCT07317609

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

A Phase 1 study testing Tislelizumab, Carboplatin and Nab-paclitaxel in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Shanghai Zhongshan Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tislelizumab, Carboplatin and Nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
15 Jul 2025to 30 Sep 2027
Phase
Phase 1
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

  • Age range: 18-80 years old;
  • Patients diagnosed with esophageal squamous cell carcinoma (ESCC) through histopathological examination of biopsy tissues from the primary tumor;
  • 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;
  • Patients with a preoperative Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  • Patients with a preoperative American Society of Anesthesiologists (ASA) physical status classification of I-III;
  • Female patients of reproductive age should have a negative pregnancy test and be willing to use effective contraceptive methods during the study period;
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  • Patients who have signed the informed consent form.
  • 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;
  • Patients who have signed the informed consent form.

Who cannot join

  • 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;
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  • 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:
  • Patients with allergies to the drugs or related components involved in this study;
  • Patients who are currently participating in any other clinical study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Li-Yun Ma, MD contact

+86 13162909612

maly14@fudan.edu.cn

China1 site, 1 recruiting

  • Shanghai Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

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

    Recruiting

Other trials in China

About this study

Official title: Safety and Feasibility of Neoadjuvant Immunotherapy Combined With Chemotherapy Sequenced With Endoscopic Resection for Esophageal Cancer (Endosurgery-02)

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.

Being tested
Tislelizumab, Carboplatin, Nab-paclitaxel, Endoscopic resection, Esophagectomy
Keywords
neoadjuvant, chemoimmunotherapy, tislelizumab, carboplatin, nab-paclitaxel, endoscopic submucosal dissection/ESD
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.

  • TislelizumabDrug

    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.

  • CarboplatinDrug

    Intervention Description: AUC 3-5 IV on Day 1, Q3W, for ≥2 cycles in combination with tislelizumab and nab-paclitaxel as neoadjuvant therapy.

  • 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.

  • Endoscopic resectionProcedure or surgery

    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.

  • EsophagectomyProcedure or surgery

    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 chemoradiationRadiation

    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.

Study groups in NCT07317609
Study groupRoleWhat they receive
Neoadjuvant Tislelizumab + Carboplatin + Nab-PaclitaxelExperimentalParticipants 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.
Receives: Drug: Tislelizumab; Drug: Carboplatin; Drug: Nab-paclitaxel; Procedure: Endoscopic resection; Procedure: Esophagectomy; Radiation: Concurrent chemoradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 12 months after completion of neoadjuvant therapy

  2. 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

    Measured: Adverse event was assessed peri-procedural of drug-using, endoscopic procedures, surgery, or radiation up to 30 days

  3. 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.

    Measured: From Day 1 of the first neoadjuvant dose to 24 months

  4. Biomarkers

    Tumor tissue samples and blood samples will be collected for tumor biomarker analysis, including but not limited to analyses of metabolic markers, circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), T-cell receptor sequencing (TCR-seq), and RNA sequencing (RNA-seq).

    Measured: Baseline and the day 1 of endoscopy or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2026
  2. Study start15 Jul 2025
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07317609
Sponsor's protocol ID
ShanghaiZhongshanEndosurgery02
Acronym
Endosurgery-02
Status last verified
Jan 2026
First submitted
25 Nov 2025
Last updated
5 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37433041

  • 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.

    PubMed 31319389

  • NCT02551458

  • Noordman 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.

    PubMed 29409469

  • Zhang 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.

    PubMed 32143580

  • Noordman BJ, Spaander MCW, Valkema R, Wijnhoven BPL, van Berge Henegouwen MI, Shapiro J, Biermann K, van der Gaast A, van Hillegersberg R, Hulshof MCCM, Krishnadath KK, Lagarde SM, Nieuwenhuijzen GAP, Oostenbrug LE, Siersema PD, Schoon EJ, Sosef MN, Steyerberg EW, van Lanschot JJB; SANO study group. Detection of residual disease after neoadjuvant chemoradiotherapy for oesophageal cancer (preSANO): a prospective multicentre, diagnostic cohort study. Lancet Oncol. 2018 Jul;19(7):965-974. doi: 10.1016/S1470-2045(18)30201-8. Epub 2018 Jun 1.

    PubMed 29861116

  • Ge F, Huo Z, Cai X, Hu Q, Chen W, Lin G, Zhong R, You Z, Wang R, Lu Y, Wang R, Huang Q, Zhang H, Song A, Li C, Wen Y, Jiang Y, Liang H, He J, Liang W, Liu J. Evaluation of Clinical and Safety Outcomes of Neoadjuvant Immunotherapy Combined With Chemotherapy for Patients With Resectable Esophageal Cancer: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022 Nov 1;5(11):e2239778. doi: 10.1001/jamanetworkopen.2022.39778.

    PubMed 36322089

  • Wang J, Zhang K, Liu T, Song Y, Hua P, Chen S, Li J, Liu Y, Zhao Y. Efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy in locally advanced esophageal cancer: A meta-analysis. Front Oncol. 2022 Sep 5;12:974684. doi: 10.3389/fonc.2022.974684. eCollection 2022.

    PubMed 36158679

  • Fan M, Dai L, Yan W, Yang Y, Lin Y, Chen K. Efficacy of programmed cell death protein 1 inhibitor in resection transformation treatment of esophageal cancer. Thorac Cancer. 2021 Aug;12(15):2182-2188. doi: 10.1111/1759-7714.14054. Epub 2021 Jun 17.

    PubMed 34137505

  • Sun JM, Shen L, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Mansoor W, Li SH, Sunpaweravong P, Maqueda MA, Goekkurt E, Hara H, Antunes L, Fountzilas C, Tsuji A, Oliden VC, Liu Q, Shah S, Bhagia P, Kato K; KEYNOTE-590 Investigators. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study. Lancet. 2021 Aug 28;398(10302):759-771. doi: 10.1016/S0140-6736(21)01234-4.

    PubMed 34454674

  • Chan KKW, Saluja R, Delos Santos K, Lien K, Shah K, Cramarossa G, Zhu X, Wong RKS. Neoadjuvant treatments for locally advanced, resectable esophageal cancer: A network meta-analysis. Int J Cancer. 2018 Jul 15;143(2):430-437. doi: 10.1002/ijc.31312. Epub 2018 Mar 8.

    PubMed 29441562

  • Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

    PubMed 26808342

  • Medical Research Council Oesophageal Cancer Working Group. Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1727-33. doi: 10.1016/S0140-6736(02)08651-8.

    PubMed 12049861

  • Morgan E, Soerjomataram I, Rumgay H, Coleman HG, Thrift AP, Vignat J, Laversanne M, Ferlay J, Arnold M. The Global Landscape of Esophageal Squamous Cell Carcinoma and Esophageal Adenocarcinoma Incidence and Mortality in 2020 and Projections to 2040: New Estimates From GLOBOCAN 2020. Gastroenterology. 2022 Sep;163(3):649-658.e2. doi: 10.1053/j.gastro.2022.05.054. Epub 2022 Jun 4.

    PubMed 35671803

  • Sugimura K, Miyata H, Tanaka K, Makino T, Takeno A, Shiraishi O, Motoori M, Yamasaki M, Kimura Y, Hirao M, Fujitani K, Yasuda T, Mori M, Eguchi H, Yano M, Doki Y. Multicenter Randomized Phase 2 Trial Comparing Chemoradiotherapy and Docetaxel Plus 5-Fluorouracil and Cisplatin Chemotherapy as Initial Induction Therapy for Subsequent Conversion Surgery in Patients With Clinical T4b Esophageal Cancer: Short-term Results. Ann Surg. 2021 Dec 1;274(6):e465-e472. doi: 10.1097/SLA.0000000000004564.

    PubMed 33065643

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tislelizumab, Carboplatin and Nab-paclitaxel in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Shanghai Zhongshan Hospital 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 13 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 5 Jan 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Li-Yun Ma, MD (+86 13162909612, maly14@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Organ preservation rate (time frame: Up to 12 months after completion of neoadjuvant therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07317609, which also lists 16 linked publications.

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 5 Jan 2026.

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