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Esophageal Squamous Cell CarcinomaPhase 2NCT07799077

Paclitaxel Polymeric Micelles and Cisplatin Plus Sintilimab as Neoadjuvant Therapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Paclitaxel polymer micelles for injection and cisplatin combined with sintilimab in people with Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Locally advanced Esophageal Squamous Cell Carcinoma (ESCC) has poor prognosis with standard therapies. Neoadjuvant immunochemotherapy improves pathological response rates, but optimal regimens remain undefined. Paclitaxel polymeric micelles offer enhanced tumor targeting (EPR effect) and reduced toxicity vs. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Paclitaxel polymer micelles for injection and cisplatin combined with sintilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
1 Sep 2026to 1 Oct 2029
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent was signed before the implementation of any test-related procedures ;
  • Age 18-75 years ;
  • Esophageal squamous cell carcinoma confirmed by histopathology ;
  • Resectable thoracic cT1b-2N1-3M0 or cT2-3N0M0 ;
  • No anti-tumor treatment has been received ;
  • ECOG PS 0-1 ;
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  • Expected survival ≥ 3 months ;
  • At least one measurable lesion per RECIST v1.1;
  • Adequate organ function (hematology, liver, kidney, coagulation, thyroid, myocardial enzymes) ;
  • For women of childbearing age, a negative urine or serum pregnancy test should be performed within three days prior to the first study drug administration ( day 1 of the first cycle ). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is required. Women of non-fertility age were defined as at least 1 year after menopause, or had undergone surgical sterilization or hysterectomy ;
  • If there is a risk of conception, all subjects ( male or female ) are required to use contraception with an annual failure rate of less than 1 % throughout the treatment period up to 120 days after the last study drug administration ( or 180 days after the last study drug administration ).

Who cannot join

  • High risk of tracheoesophageal fistula or aortoesophageal fistula
  • Prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy
  • Participation in another interventional clinical trial within 4 weeks before the first dose
  • History of other active malignancies (except cured low-risk tumors, adequately treated non-melanoma skin cancer, or carcinoma in situ)
  • Active uncontrolled hepatitis B/C infection
  • Uncontrolled systemic diseases (e.g., heart failure NYHA ≥II, interstitial lung disease, active autoimmune diseases requiring systemic immunosuppression)
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  • Allergy to study drugs or excipients
  • Uncontrolled third-space effusion (e.g., pleural/pericardial effusion)
  • Pregnant or lactating women

Trial locations and contacts

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

Ziqiang Tian contact

+8618538881000

tizq12@vip.163.com

China1 site

  • The Fourth Hospital of Hebei Medical University

    Hebei, Shijiazhuang

    Ziqiang Tian, +8618531118000, tizq12@vip.163.com

Other trials in China

About this study

Official title: Paclitaxel Polymeric Micelles and Cisplatin Plus Sintilimab as Neoadjuvant Therapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Single-arm, Multicenter, Prospective Phase II Clinical Trial

Locally advanced Esophageal Squamous Cell Carcinoma (ESCC) has poor prognosis with standard therapies. Neoadjuvant immunochemotherapy improves pathological response rates, but optimal regimens remain undefined. Paclitaxel polymeric micelles offer enhanced tumor targeting (EPR effect) and reduced toxicity vs. conventional paclitaxel formulations, with no need for premedication. This single-arm, prospective trial evaluates the efficacy and safety of neoadjuvant sintilimab combined with paclitaxel polymeric micelles and cisplatin in resectable locally advanced ESCC.

Being tested
Paclitaxel polymer micelles for injection and cisplatin combined with sintilimab
Keywords
Esophageal squamous cell carcinoma, Locally advanced resectable, Paclitaxel Polymeric Micelles
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.

  • Paclitaxel polymer micelles for injection and cisplatin combined with sintilimabDrug

    1. Sindilimab : 200 mg, Q3W, intravenous infusion, D1 ;
    2. Paclitaxel polymeric micelles : 300 mg/m2 ; q3W, intravenous infusion, D1 ;
    3. Cisplatin : 75 mg/m2 ; q3W ; intravenous infusion, D1 ;
Study groups in NCT07799077
Study groupRoleWhat they receive
Paclitaxel polymer micelles and cisplatin combined with sintilimabExperimentalNot described
Receives: Drug: Paclitaxel polymer micelles for injection and cisplatin combined with sintilimab

What is being measured

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

  1. Pathological Complete Response (pCR) rate

    Pathological Complete Response (pCR) rate: Proportion of patients with no residual invasive tumor in primary tumor bed and sampled lymph nodes (ypT0/Tis ypN0) after neoadjuvant therapy

    Measured: Assessed via surgical pathology (4-6 weeks post-neoadjuvant therapy)

Secondary outcomes (6)

  1. Major Pathological Response (MPR) rate

    Measured: Perioperative

  2. R0 resection rate

    Measured: Perioperative

  3. Objective Response Rate (ORR) per RECIST v1.1

    Measured: Assessed at baseline and pre-surgery

  4. Event-Free Survival (EFS)

    Measured: Follow-up every 3 months for 2 years, then every 6 months up to 5 years

  5. Overall Survival (OS)

    Measured: Follow-up every 3 months for 2 years, then every 6 months up to 5 years

  6. Safety: Incidence of adverse events (AEs), serious AEs (SAEs), and immune-related AEs (irAEs)

    Measured: From initiation of treatment to 30 days post-last dose (or 90 days for SAEs)

Timeline

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

  1. First posted2 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion1 Oct 2029 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07799077
Sponsor's protocol ID
ZSGJSIITRX003
Status last verified
Jul 2026
First submitted
30 Jul 2026
Last updated
2 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shi M, Gu A, Tu H, Huang C, Wang H, Yu Z, Wang X, Cao L, Shu Y, Wang H, Yang R, Li X, Chang J, Hu Y, Shen P, Hu Y, Guo Z, Tao M, Zhang Y, Liu X, Sun Q, Zhang X, Jiang Z, Zhao J, Chen F, Yu H, Zhang W, Sun J, Li D, Zhou J, Han B, Wu YL. Comparing nanoparticle polymeric micellar paclitaxel and solvent-based paclitaxel as first-line treatment of advanced non-small-cell lung cancer: an open-label, randomized, multicenter, phase III trial. Ann Oncol. 2021 Jan;32(1):85-96. doi: 10.1016/j.annonc.2020.10.479. Epub 2020 Oct 29.

    PubMed 33130217

  • Lu Z, Wang J, Shu Y, Liu L, Kong L, Yang L, Wang B, Sun G, Ji Y, Cao G, Liu H, Cui T, Li N, Qiu W, Li G, Hou X, Luo H, Xue L, Zhang Y, Yue W, Liu Z, Wang X, Gao S, Pan Y, Galais MP, Zaanan A, Ma Z, Li H, Wang Y, Shen L; ORIENT-15 study group. Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase 3 trial. BMJ. 2022 Apr 19;377:e068714. doi: 10.1136/bmj-2021-068714.

    PubMed 35440464

  • Lv H, Tian Y, Li J, Huang C, Sun B, Gai C, Li Z, Tian Z. Neoadjuvant Sintilimab Plus Chemotherapy in Resectable Locally Advanced Esophageal Squamous Cell Carcinoma. Front Oncol. 2022 Apr 29;12:864533. doi: 10.3389/fonc.2022.864533. eCollection 2022.

    PubMed 35574384

  • Yan X, Duan H, Ni Y, Zhou Y, Wang X, Qi H, Gong L, Liu H, Tian F, Lu Q, Sun J, Yang E, Zhong D, Wang T, Huang L, Wang J, Chaoyang Wang, Wang Y, Wan Z, Lei J, Zhao J, Jiang T. Tislelizumab combined with chemotherapy as neoadjuvant therapy for surgically resectable esophageal cancer: A prospective, single-arm, phase II study (TD-NICE). Int J Surg. 2022 Jul;103:106680. doi: 10.1016/j.ijsu.2022.106680. Epub 2022 May 18.

    PubMed 35595021

  • Zheng Y, Liu XB, Sun HB, Xu J, Shen S, Ba YF, Yan M, Qin Z, Liu BX, Wang ZF, Liu SL, Zhang RX, Chen PN, Liang GH, Yuan D, Li ZX, Liu Q, Wang HR, Li HM, Lv H, Ma X, Zhu J, Yu YK, Xing WQ; written on Henan Cancer Hospital Thoracic Oncology Group (HCHTOG). A phase III study on neoadjuvant chemotherapy versus neoadjuvant toripalimab plus chemotherapy for locally advanced esophageal squamous cell carcinoma: Henan Cancer Hospital Thoracic Oncology Group 1909 (HCHTOG1909). Ann Transl Med. 2021 Jan;9(1):73. doi: 10.21037/atm-20-5404.

    PubMed 33553366

  • Qin J, Xue L, Hao A, Guo X, Jiang T, Ni Y, Liu S, Chen Y, Jiang H, Zhang C, Kang M, Lin J, Li H, Li C, Tian H, Li L, Fu J, Zhang Y, Ma J, Wang X, Fu M, Yang H, Yang Z, Han Y, Chen L, Tan L, Dai T, Liao Y, Zhang W, Li B, Chen Q, Guo S, Qi Y, Wei L, Li Z, Tian Z, Kang X, Zhang R, Li Y, Wang Z, Chen X, Hou Z, Zheng R, Zhu W, He J, Li Y. Neoadjuvant chemotherapy with or without camrelizumab in resectable esophageal squamous cell carcinoma: the randomized phase 3 ESCORT-NEO/NCCES01 trial. Nat Med. 2024 Sep;30(9):2549-2557. doi: 10.1038/s41591-024-03064-w. Epub 2024 Jul 2.

    PubMed 38956195

  • Zhang Z, Hong ZN, Xie S, Lin W, Lin Y, Zhu J, Yang X, Lin Z, Lin J, Kang M. Neoadjuvant sintilimab plus chemotherapy for locally advanced esophageal squamous cell carcinoma: a single-arm, single-center, phase 2 trial (ESONICT-1). Ann Transl Med. 2021 Nov;9(21):1623. doi: 10.21037/atm-21-5381.

    PubMed 34926667

  • He W, Wang C, Li C, Nie X, Li H, Li J, Zhao N, Chen H, Miao X, Han Y, Peng L, Leng X. The efficacy and safety of neoadjuvant immunotherapy in resectable locally advanced esophageal squamous cell carcinoma: A systematic review and meta-analysis. Front Immunol. 2023 Feb 17;14:1118902. doi: 10.3389/fimmu.2023.1118902. eCollection 2023.

    PubMed 36875107

  • Faron M, Cheugoua-Zanetsie M, Tierney J, Thirion P, Nankivell M, Winter K, Yang H, Shapiro J, Vernerey D, Smithers BM, Walsh T, Piessen G, Nilsson M, Boonstra J, Ychou M, Law S, Cunningham D, de Vathaire F, Stahl M, Urba S, Valmasoni M, Williaume D, Thomas J, Lordick F, Tepper J, Roth J, Gebski V, Burmeister B, Paoletti X, van Sandick J, Fu J, Pignon JP, Ducreux M, Michiels S; MANATEC-02 Collaborative Group. Individual Participant Data Network Meta-Analysis of Neoadjuvant Chemotherapy or Chemoradiotherapy in Esophageal or Gastroesophageal Junction Carcinoma. J Clin Oncol. 2023 Oct 1;41(28):4535-4547. doi: 10.1200/JCO.22.02279. Epub 2023 Jul 12.

    PubMed 37467395

  • Kato K, Machida R, Ito Y, Daiko H, Ozawa S, Ogata T, Hara H, Kojima T, Abe T, Bamba T, Watanabe M, Kawakubo H, Shibuya Y, Tsubosa Y, Takegawa N, Kajiwara T, Baba H, Ueno M, Takeuchi H, Nakamura K, Kitagawa Y; JCOG1109 investigators. Doublet chemotherapy, triplet chemotherapy, or doublet chemotherapy combined with radiotherapy as neoadjuvant treatment for locally advanced oesophageal cancer (JCOG1109 NExT): a randomised, controlled, open-label, phase 3 trial. Lancet. 2024 Jul 6;404(10447):55-66. doi: 10.1016/S0140-6736(24)00745-1. Epub 2024 Jun 11.

    PubMed 38876133

  • Tang H, Wang H, Fang Y, Zhu JY, Yin J, Shen YX, Zeng ZC, Jiang DX, Hou YY, Du M, Lian CH, Zhao Q, Jiang HJ, Gong L, Li ZG, Liu J, Xie DY, Li WF, Chen C, Zheng B, Chen KN, Dai L, Liao YD, Li K, Li HC, Zhao NQ, Tan LJ. Neoadjuvant chemoradiotherapy versus neoadjuvant chemotherapy followed by minimally invasive esophagectomy for locally advanced esophageal squamous cell carcinoma: a prospective multicenter randomized clinical trial. Ann Oncol. 2023 Feb;34(2):163-172. doi: 10.1016/j.annonc.2022.10.508. Epub 2022 Nov 15.

    PubMed 36400384

  • Ando N, Kato H, Igaki H, Shinoda M, Ozawa S, Shimizu H, Nakamura T, Yabusaki H, Aoyama N, Kurita A, Ikeda K, Kanda T, Tsujinaka T, Nakamura K, Fukuda H. A randomized trial comparing postoperative adjuvant chemotherapy with cisplatin and 5-fluorouracil versus preoperative chemotherapy for localized advanced squamous cell carcinoma of the thoracic esophagus (JCOG9907). Ann Surg Oncol. 2012 Jan;19(1):68-74. doi: 10.1245/s10434-011-2049-9. Epub 2011 Aug 31.

    PubMed 21879261

  • Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Lordick F, D'Journo XB, Cerfolio RJ, Korst RJ, Novoa NM, Swanson SJ, Brunelli A, Ismail M, Fernando HC, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J; AME Thoracic Surgery Collaborative Group. Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial. J Clin Oncol. 2018 Sep 20;36(27):2796-2803. doi: 10.1200/JCO.2018.79.1483. Epub 2018 Aug 8.

    PubMed 30089078

  • van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.

    PubMed 22646630

  • Kitagawa Y, Ishihara R, Ishikawa H, Ito Y, Oyama T, Oyama T, Kato K, Kato H, Kawakubo H, Kawachi H, Kuribayashi S, Kono K, Kojima T, Takeuchi H, Tsushima T, Toh Y, Nemoto K, Booka E, Makino T, Matsuda S, Matsubara H, Mano M, Minashi K, Miyazaki T, Muto M, Yamaji T, Yamatsuji T, Yoshida M. Esophageal cancer practice guidelines 2022 edited by the Japan esophageal society: part 1. Esophagus. 2023 Jul;20(3):343-372. doi: 10.1007/s10388-023-00993-2. Epub 2023 Mar 18. No abstract available.

    PubMed 36933136

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel polymer micelles for injection and cisplatin combined with sintilimab in people with Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth 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 11 inclusion and 9 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: opening soon, as of the sponsor's last update on 2 Sep 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Ziqiang Tian (+8618538881000, tizq12@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response (pCR) rate (time frame: Assessed via surgical pathology (4-6 weeks post-neoadjuvant therapy)). 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 NCT07799077, which also lists 19 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 2 Sep 2026.

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