Esophageal Squamous Cell CarcinomaPhase 3HCHTOG2603NCT07629817
Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy
A Phase 3 study testing Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy, Radiation with Concurrent Chemotherapy and Radical Esophagectomy in people with Esophageal Squamous Cell Carcinoma, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This is a Phase III, multicenter, open-label, randomized controlled trial. The study aims to compare organ preservation versus esophagectomy in patients with locally advanced, resectable thoracic esophageal squamous cell carcinoma (ESCC) who achieve a complete or partial clinical response (cCR/cPR) following… 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?
- Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy, Radiation with Concurrent Chemotherapy and Radical Esophagectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,044 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2026to 15 Mar 2032
- Phase
- Phase 3
- 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
- Age 18-75 years, any sex.
- ECOG Performance Status 0-1.
- Histologically confirmed, previously untreated thoracic esophageal squamous cell carcinoma (ESCC).
- Clinical stage cT2N0M0, T3N0-2M0 (AJCC 8th Edition), assessed as resectable with a potential for R0 resection by endoscopic ultrasound (EUS), PET-CT, and contrast-enhanced CT. Patients with cervical lymph node metastasis may also be included if deemed suitable for three-field lymphadenectomy by a multidisciplinary team assessment.
- Adequate bone marrow, hepatic, and renal function:
- Absolute neutrophil count ≥ 1.5 × 10⁹/L, Platelet count ≥ 100 × 10⁹/L, Hemoglobin ≥ 90 g/L.
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- Alanine aminotransferase / Aspartate aminotransferase ≤ 2.5 × Upper Limit of Normal, Total bilirubin ≤ 1.5 × Upper Limit of Normal.
- Serum creatinine ≤ 1.5 × Upper Limit of Normal or Creatinine clearance ≥ 60 mL/min.
- Signed written informed consent form (ICF).
Who cannot join
- History of other malignancy within the past 5 years.
- Active autoimmune disease.
- Active Hepatitis B Virus (HBV) / Hepatitis C Virus (HCV) / Human Immunodeficiency Virus (HIV) infection.
- Severe cardiac or pulmonary insufficiency (Left Ventricular Ejection Fraction < 50%, Forced Expiratory Volume in 1 second < 1 L).
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Yan Zheng, M.D./Ph.D, +86-371-65587610, hnszlyylixiang@163.com
About this study
Official title: A Multicenter, Open-Label, Randomized Controlled Phase III Clinical Trial Comparing Surgery Versus Radical Chemoradiotherapy (Organ Preservation) in Patients With Thoracic Esophageal Squamous Cell Carcinoma Achieving cCR or cPR Following Neoadjuvant Immunochemotherapy
This is a Phase III, multicenter, open-label, randomized controlled trial. The study aims to compare organ preservation versus esophagectomy in patients with locally advanced, resectable thoracic esophageal squamous cell carcinoma (ESCC) who achieve a complete or partial clinical response (cCR/cPR) following neoadjuvant immunochemotherapy.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy, Radiation with Concurrent Chemotherapy, Radical Esophagectomy
- 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.
Toripalimab + Nab-paclitaxel + Platinum-based ChemotherapyDrug
This is the standard induction therapy administered to all enrolled patients. It consists of the PD-1 inhibitor Toripalimab combined with Nab-paclitaxel
Radiation with Concurrent ChemotherapyCombination product
Chemotherapy administered concurrently with radiotherapy
Radical EsophagectomyProcedure or surgery
Standard surgical procedure with lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| Organ Preservation with Radical Chemoradiotherapy | Experimental | Patients achieving clinical complete or partial response (cCR/cPR) after neoadjuvant immunochemotherapy will receive definitive chemoradiotherapy for organ preservation. Radiotherapy (50.4 Gy/28 fractions, IMRT) with concurrent weekly chemotherapy (e.g., paclitaxel + cisplatin). Patients with ycCR after chemoradiotherapy will enter observation. Patients with residual disease will undergo salvage esophagectomy. Receives: Drug: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy; Combination Product: Radiation with Concurrent Chemotherapy |
| Immediate Esophagectomy | Experimental | Patients achieving cCR/cPR after neoadjuvant immunochemotherapy will undergo immediate radical esophagectomy (McKeown or Ivor-Lewis procedure) with 2-field or 3-field lymph node dissection. Postoperative immunotherapy (up to 8 cycles) may be administered based on pathological findings (ypT≥1 or N+). Receives: Drug: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy; Procedure: Radical Esophagectomy |
| Non-Responder Surgery | Active comparator | Patients with stable disease (cSD) or progressive disease (cPD) after neoadjuvant immunochemotherapy will undergo immediate radical esophagectomy, which is the standard of care for this subgroup. Postoperative treatment is determined by pathological findings. Receives: Drug: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy; Procedure: Radical Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Event-Free Survival (EFS) Rate
Event-Free Survival is defined as the time from randomization (for responders) or from the start of neoadjuvant therapy (for the overall population) until the occurrence of any of the following events:
Local recurrence of esophageal cancer. Distant metastasis. Death from any cause
Measured: 3 years after randomization/treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start16 Jun 2026
- Primary completion15 Mar 2032 (estimated)
- Study completion15 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,044 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629817
- Sponsor's protocol ID
- 2026-150
- Acronym
- HCHTOG2603
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Randomized Controlled Phase III Clinical Trial Comparing Surgery Versus Radical Chemoradiotherapy (Organ Preservation) in Patients With Thoracic Esophageal Squamous Cell Carcinoma Achieving cCR or cPR Following Neoadjuvant Immunochemotherapy
- ClinicalTrials.gov ID
- NCT07629817
- Acronym / sponsor ID
- HCHTOG2603 / 2026-150
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,044 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 15 Mar 2032 (estimated)
- Study completion
- 15 Mar 2032 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III, multicenter, open-label, randomized controlled trial. The study aims to compare organ preservation versus esophagectomy in patients with locally advanced, resectable thoracic esophageal squamous cell carcinoma (ESCC) who achieve a complete or partial clinical response (cCR/cPR) following neoadjuvant immunochemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Organ Preservation with Radical Chemoradiotherapy | Experimental | Drug: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy, Combination Product: Radiation with Concurrent ChemotherapyPatients achieving clinical complete or partial response (cCR/cPR) after neoadjuvant immunochemotherapy will receive definitive chemoradiotherapy for organ preservation. Radiotherapy (50.4 Gy/28 fractions, IMRT) with concurrent weekly chemotherapy (e.g., paclitaxel + cisplatin). Patients with ycCR after chemoradiotherapy will enter observation. Patients with residual disease will undergo salvage esophagectomy. |
| Immediate Esophagectomy | Experimental | Drug: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy, Procedure: Radical EsophagectomyPatients achieving cCR/cPR after neoadjuvant immunochemotherapy will undergo immediate radical esophagectomy (McKeown or Ivor-Lewis procedure) with 2-field or 3-field lymph node dissection. Postoperative immunotherapy (up to 8 cycles) may be administered based on pathological findings (ypT≥1 or N+). |
| Non-Responder Surgery | Active comparator | Drug: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy, Procedure: Radical EsophagectomyPatients with stable disease (cSD) or progressive disease (cPD) after neoadjuvant immunochemotherapy will undergo immediate radical esophagectomy, which is the standard of care for this subgroup. Postoperative treatment is determined by pathological findings. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-75 years, any sex.
- ECOG Performance Status 0-1.
- Histologically confirmed, previously untreated thoracic esophageal squamous cell carcinoma (ESCC).
- Clinical stage cT2N0M0, T3N0-2M0 (AJCC 8th Edition), assessed as resectable with a potential for R0 resection by endoscopic ultrasound (EUS), PET-CT, and contrast-enhanced CT. Patients with cervical lymph node metastasis may also be included if deemed suitable for three-field lymphadenectomy by a multidisciplinary team assessment.
- Adequate bone marrow, hepatic, and renal function:
Key exclusion criteria (5 listed)
- History of other malignancy within the past 5 years.
- Active autoimmune disease.
- Active Hepatitis B Virus (HBV) / Hepatitis C Virus (HCV) / Human Immunodeficiency Virus (HIV) infection.
- Severe cardiac or pulmonary insufficiency (Left Ventricular Ejection Fraction < 50%, Forced Expiratory Volume in 1 second < 1 L).
- Pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toripalimab + Nab-paclitaxel + Platinum-based ChemotherapyThis is the standard induction therapy administered to all enrolled patients. It consists of the PD-1 inhibitor Toripalimab combined with Nab-paclitaxel | Drug | Immediate Esophagectomy, Non-Responder Surgery, Organ Preservation with Radical Chemoradiotherapy |
| Radiation with Concurrent ChemotherapyChemotherapy administered concurrently with radiotherapy | Combination product | Organ Preservation with Radical Chemoradiotherapy |
| Radical EsophagectomyStandard surgical procedure with lymph node dissection | Procedure or surgery | Immediate Esophagectomy, Non-Responder Surgery |
Primary outcome
3-year Event-Free Survival (EFS) Rate
Time frame: 3 years after randomization/treatment initiation
Event-Free Survival is defined as the time from randomization (for responders) or from the start of neoadjuvant therapy (for the overall population) until the occurrence of any of the following events: Local recurrence of esophageal cancer. Distant metastasis. Death from any cause
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy, Radiation with Concurrent Chemotherapy and Radical Esophagectomy in people with Esophageal Squamous Cell Carcinoma, run by Henan Cancer 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 9 inclusion and 5 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 31 Jul 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yan Zheng, M.D./Ph.D ((+86)0371-65587610, hnszlyylixiang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Event-Free Survival (EFS) Rate (time frame: 3 years after randomization/treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2026.