NCT07711470

Brief Summary

This multicenter, prospective Phase II study investigates a response-adapted organ-preservation strategy in patients with resectable esophageal squamous cell carcinoma (ESCC). Participants will receive two cycles of induction chemoimmunotherapy with sugemalimab, nab-paclitaxel, and cisplatin. Patients who achieve a major clinical response will receive definitive radiotherapy plus sugemalimab followed by maintenance sugemalimab, while non-major responders will undergo surgery-based treatment strategies. The study aims to evaluate the efficacy and safety of this tailored treatment approach, with the primary endpoint being 2-year progression-free survival. Secondary and exploratory objectives include survival outcomes, quality of life, nutritional status.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
37mo left

Started Jul 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Jul 2029

Study Start

First participant enrolled

July 1, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2029

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

2.5 years

First QC Date

July 14, 2026

Last Update Submit

July 14, 2026

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Outcome Measures

Primary Outcomes (1)

  • 2-year PFS rate

    Up to 2 years after initiation of treatment

Study Arms (3)

Major Response Organ Preservation Group

EXPERIMENTAL

Participants with a major clinical response after induction chemoimmunotherapy will receive radiotherapy plus sugemalimab followed by maintenance sugemalimab for organ preservation.

Drug: Sugemalimab and ChemotherapyDrug: Nab-paclitaxelDrug: CisplatinRadiation: Radiation Therapy

Surgery Group

ACTIVE COMPARATOR

Participants with partial response or stable disease after induction therapy will undergo surgical resection.

Drug: Sugemalimab and ChemotherapyDrug: Nab-paclitaxelDrug: Cisplatin

Radiotherapy Followed by Surgery Group

ACTIVE COMPARATOR

Participants with partial response or stable disease after induction therapy will receive radiotherapy followed by surgical resection.

Drug: Sugemalimab and ChemotherapyDrug: Nab-paclitaxelDrug: CisplatinRadiation: Radiation Therapy

Interventions

Sugemalimab and ChemotherapyDRUG

Sugemalimab 1200 mg administered intravenously every 3 weeks as induction, and maintenance immunotherapy.

Major Response Organ Preservation GroupRadiotherapy Followed by Surgery GroupSurgery Group
Nab-paclitaxelDRUG

125 mg/m² administered intravenously on Days 1 and 8 every 3 weeks during induction therapy.

Major Response Organ Preservation GroupRadiotherapy Followed by Surgery GroupSurgery Group
CisplatinDRUG

75 mg/m² administered intravenously on Day 1 every 3 weeks during induction therapy.

Major Response Organ Preservation GroupRadiotherapy Followed by Surgery GroupSurgery Group
Radiation TherapyRADIATION

IMRT: PTV 41.4 Gy/23f，PGTV 49.45 Gy/23f

Major Response Organ Preservation GroupRadiotherapy Followed by Surgery Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years. Histologically confirmed, previously untreated resectable esophageal squamous cell carcinoma (ESCC).
  • Clinical stage IB-III according to AJCC 8th edition. ECOG performance status 0-1. Adequate hematologic, hepatic, and renal function. Ability to provide written informed consent.

You may not qualify if:

  • Prior systemic therapy, radiotherapy, surgery, or immunotherapy for ESCC. Distant metastases or suspicious cervical lymph node metastases. Prior treatment with PD-1 or PD-L1 inhibitors. Active autoimmune disease requiring systemic treatment. Uncontrolled infection, including active hepatitis or HIV infection. Significant cardiovascular, pulmonary, or other serious medical conditions that may interfere with study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

sugemalimabDrug Therapy130-nm albumin-bound paclitaxelCisplatinRadiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 17, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

July 31, 2029

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)