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Esophageal Malignant Neoplasm PrimaryPhase 2LA-ESCCNCT06888531

Prospective Phase II Clinical Study of Neoadjuvant Chemoradiotherapy Combined With PD-1/PD-L1 Inhibitors in the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Neoadjuvant chemoradiotherapy combined with PD-1/PD-L1 inhibitors for the treatment of locally advanced resectable esophageal squamous cell carcinoma in people with Esophageal Malignant Neoplasm Primary, run by Henan Cancer Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A prospective trial design was used to evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1/PD-L1 inhibitors in the treatment of locally advanced resectable esophageal squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Malignant Neoplasm Primary
What is being tested?
Neoadjuvant chemoradiotherapy combined with PD-1/PD-L1 inhibitors for the treatment of locally advanced resectable esophageal squamous cell carcinoma
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
8 Mar 2025to 31 Dec 2027
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

  • Age ≥ 18 years and ≤ 75 years
  • ECOG performance score 0-1
  • Histologically or pathologically confirmed resectable thoracic esophageal squamous cell carcinoma, clinical stage T1b-2 N+ M0 or T3-4a anyN M0 (AJCC 8th)
  • No prior anti-tumor treatment before surgery
  • At least one measurable lesion (according to RECIST 1.1 criteria).
  • Normal major organ function

Who cannot join

  • Allergic to the treatment drugs
  • Patients who have received or are currently receiving other chemotherapy, radiotherapy, immunotherapy or targeted therapy
  • Patients with tumors that have invaded major blood vessels as shown by imaging or those judged by the investigator to be highly likely to invade major blood vessels and cause fatal hemorrhage during the subsequent study period
  • Patients with other malignant tumors that require active treatment within 5 years of the study (except for those that have been adequately treated, such as basal cell or squamous cell skin cancer with an expected 5-year survival rate > 90%, cervical carcinoma in situ, and ductal carcinoma in situ of the breast)
  • Patients with active autoimmune diseases or immunodeficiency
  • Patients who are currently using immunosuppressants or systemic hormones for immunosuppression purposes (dose > 10mg/day of prednisone or other equivalent efficacy hormones) and have continued to use them within 2 weeks before enrollment
Show all 14Show fewer
  • Patients who have received systemic treatment with high-dose antibiotics within the past 2 weeks
  • Patients who have experienced arterial or venous thrombotic events within 6 months before the first administration, including cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis and pulmonary embolism
  • Patients with digestive tract diseases or conditions that may affect drug absorption, including but not limited to active gastric and duodenal ulcers, ulcerative colitis or unremoved gastrointestinal tumors with active bleeding, or other conditions judged by the investigator to be likely to cause gastrointestinal bleeding or perforation, and those with multiple factors affecting oral drug administration (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)
  • Patients with significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; congestive heart failure with New York Heart Association (NYHA) classification ≥ 2; drug-treated ventricular arrhythmias (including QTc interval ≥ 450 ms for men and ≥ 470 ms for women); left ventricular ejection fraction (LVEF) < 50%
  • Patients with active or uncontrolled severe infections (≥ CTCAE5.0 grade 2 infections), including but not limited to hospitalization due to infectious complications, bacteremia or severe pneumonia, and unexplained fever > 38.5°C before the first administration
  • Patients with symptomatic pleural effusion, pericardial effusion or ascites that require frequent drainage as judged by the investigator
  • Patients with liver cirrhosis or active hepatitis; for hepatitis B, HBsAg positive and HBV DNA exceeding the upper limit of normal (1000 copies/ml or 500 IU/ml); patients with a history of hepatitis B virus (HBV) infection or cured HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and the absence of HBsAg, and normal HBV DNA value during the screening period can be included); for hepatitis C, HCV antibody positive and HCV viral load exceeding the upper limit of normal/HCV RNA or HCV Ab test indicating acute or chronic infection. 14. Patients with urine routine test indicating urine protein ≥++, and confirmed 24-hour urine protein quantification > 1.0g
  • 15. Patients with a history of abuse of psychotropic drugs and unable to quit or with mental disorders 16. Patients with pulmonary fibrosis, pneumoconiosis, radiation pneumonitis, drug-induced pneumonia and severe pulmonary function impairment 17. Pregnant women (positive pregnancy test before medication) or women who are breastfeeding 18. Patients who have undergone surgery (excluding biopsy) within 28 days before enrollment in this study or whose surgical incision has not completely healed 19. Patients who have received or plan to receive live attenuated vaccines within 4 weeks before the first dose 20. Patients who have received any other investigational drug treatment or participated in other interventional studies within 4 weeks before signing the informed consent form 21. Patients who, in the judgment of the investigator, are not suitable for inclusion in the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Henan Cancer Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Prospective Phase II Clinical Study of Neoadjuvant Chemoradiotherapy Combined With PD-1/PD-L1 Inhibitors In the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

A prospective trial design was used to evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1/PD-L1 inhibitors in the treatment of locally advanced resectable esophageal squamous cell carcinoma.

Read the detailed description

This study is aimed at resectable thoracic esophageal squamous cell carcinoma with clinical stage T1b-2 N+ M0 or T3-4a anyN M0 (AJCC 8th). The primary endpoint of the study is pathological complete response (pCR). A total of 30 patients with locally advanced resectable esophageal squamous cell carcinoma will be enrolled in the trial after providing informed consent and passing the screening process. The treatment regimens include: Toripalimab: intravenous infusion, 240mg, D1, Q3W, for 2 consecutive doses; or Envorimab: subcutaneous injection, 400mg, D1, Q3W, for 2 consecutive doses. Albumin-bound paclitaxel: intravenous infusion, 50mg/m2, D1, QW, for 5 consecutive doses. Carboplatin: intravenous infusion, AUC=2, D1, QW, for 5 consecutive doses. Radiotherapy: 41.4Gy/1.8Gy/23F, D1-5, 5 times per week.

Being tested
Neoadjuvant chemoradiotherapy combined with PD-1/PD-L1 inhibitors for the treatment of locally advanced resectable esophageal squamous cell carcinoma
Keywords
LA-ESCC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neoadjuvant chemoradiotherapy combined with PD-1/PD-L1 inhibitors for the treatment of locally advanced resectable esophageal squamous cell carcinomaCombination product

    Also called LA-ESCC

    Toripalimab: intravenous infusion, 240mg, D1, Q3W, for 2 consecutive doses; or Envorimab: subcutaneous injection, 400mg, D1, Q3W, for 2 consecutive doses. Albumin-bound paclitaxel: intravenous infusion, 50mg/m2, D1, QW, for 5 consecutive doses. Carboplatin: intravenous infusion, AUC=2, D1, QW, for 5 consecutive doses. Radiotherapy: 41.4Gy/1.8Gy/23F, D1-5, 5 times per week.

Study groups in NCT06888531
Study groupRoleWhat they receive
Treatment GroupExperimentalToripalimab: intravenous infusion, 240mg, D1, Q3W, for 2 consecutive doses; or Envorimab: subcutaneous injection, 400mg, D1, Q3W, for 2 consecutive doses. Albumin-bound paclitaxel: intravenous infusion, 50mg/m2, D1, QW, for 5 consecutive doses. Carboplatin: intravenous infusion, AUC=2, D1, QW, for 5 consecutive doses. Radiotherapy: 41.4Gy/1.8Gy/23F, D1-5, 5 times per week.
Receives: Combination Product: Neoadjuvant chemoradiotherapy combined with PD-1/PD-L1 inhibitors for the treatment of locally advanced resectable esophageal squamous cell carcinoma

What is being measured

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

  1. Pathologic complete response

    pCR

    Measured: From enrollment to the end of treatment at 2 years

Secondary outcomes (1)

  1. Major pathologic response

    MPR

    Measured: From enrollment to the end of treatment at 2 years

Timeline

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

  1. First posted21 Mar 2025
  2. Study start8 Mar 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06888531
Sponsor's protocol ID
LA-ESCC-II-01
Acronym
LA-ESCC
Status last verified
Feb 2025
First submitted
5 Mar 2025
Last updated
21 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neoadjuvant chemoradiotherapy combined with PD-1/PD-L1 inhibitors for the treatment of locally advanced resectable esophageal squamous cell carcinoma in people with Esophageal Malignant Neoplasm Primary, 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 6 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 21 Mar 2025. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic complete response (time frame: From enrollment to the end of treatment at 2 years). 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 NCT06888531.

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 21 Mar 2025.

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