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PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC

Primary Purpose

Squamous Cell Esophageal Carcinoma, Esophageal Cancer, Oesophageal Cancer

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Sintilimab

Preoperative radiotherapy

Paclitaxel

Cisplatin

esophagectomy

About this trial

This is an interventional treatment trial for Squamous Cell Esophageal Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable.
Patients must not have received any prior anticancer therapy.
More than 6 months of expected survival.
Age ranges from 18 to 70 years.
Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
WHO PS score 0-1
Signed informed consent document on file.

Exclusion Criteria:

Patients have received any prior anticancer therapy.
Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin.
Patients with concomitant hemorrhagic disease.
Patients who cannot tolerate surgery.
Pregnant or breast feeding.
Patients without informed consent because of psychological, family, social or any other factors.
Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.
Patients with history of diabetes over 10 years and unsatisfactory glycemic control.
Patients with severe heart,lung,liver,renal dysfunction, hematopoietic system diseases, immune system diseases, cachexia or other diseases that lead to intolerance of chemoradiotherapy or surgery.
Patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation.
Patients with history of interstitial lung disease or noninfectious pneumonia.
Patients with active pulmonary tuberculosis infection, or a history of active pulmonary tuberculosis infection within one year before enrollment, or a history of active pulmonary tuberculosis infection more than one year ago without regular treatment.
Patients with active hepatitis B ( HBV DNA ≥ 2000 IU / mL or 104 copies / mL ) or hepatitis C ( HCV antibody positive ).

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NCRT+IO group

NCRT group

Arm Description

• NCRT+IO group consists of the PD-1 inhibitor combined with concurrent chemoradiotherapy prior to surgery. The patient will receive 4 weeks of radiation therapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks.PD-1 inhibitor is given by intravenous infusion on days 1 and 22. Chemotherapy is given by intravenous infusion on days 1, 8, 15, and 22. Interventions: Radiation: (40 or 45 Gy/20 fractions) Drug: Sintilimab Drug: Paclitaxel Drug: Cisplatin

• NCRT group consists of the concurrent chemoradiotherapy prior to surgery. The patient will receive 4 weeks of radiation therapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks. Chemotherapy is given by intravenous infusion on days 1, 8, 15, and 22. Interventions: Radiation: (40 or 45 Gy/20 fractions) Drug: Paclitaxel Drug: Cisplatin

Outcomes

Primary Outcome Measures

Overall survival

Overall survival will be calculated from the date of randomization and an event registered on the date of death from any cause. Patients lost to follow up, or those with no death recorded on the day the database is frozen, will be censored on the date of last follow up.

Secondary Outcome Measures

Progression free survival

Progression free survival is defined as the time from randomization until objective tumor progression or death.

Pathologic complete response rate

No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes

R0 resection rate

The percentage of patients who undergo complete resection

Incidence of perioperative complications

Incidence of complications

Perioperative mortality

Incidence of death postoperatively

Full Information

NCT ID

NCT05357846

First Posted

March 22, 2022

Last Updated

November 11, 2022

Sponsor

Sun Yat-sen University

Collaborators

Affiliated Cancer Hospital of Shantou University Medical College

1. Study Identification

Unique Protocol Identification Number

NCT05357846

Brief Title

PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC

Official Title

Phase III Multicenter Randomized Controlled Trial of PD-1 Inhibitor Combined With Preoperative Concurrent Chemoradiotherapy and Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2022 (Actual)

Primary Completion Date

January 2031 (Anticipated)

Study Completion Date

January 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

Affiliated Cancer Hospital of Shantou University Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Esophageal Carcinoma, Esophageal Cancer, Oesophageal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

422 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NCRT+IO group

Arm Type

Experimental

Arm Description

Arm Title

NCRT group

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sintilimab

Intervention Description

Sintilimab 200mg, IV (in the vein) on day 1 and day 22

Intervention Type

Radiation

Intervention Name(s)

Preoperative radiotherapy

Intervention Description

External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

Taxol

Intervention Description

50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

DDP

Intervention Description

25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22

Intervention Type

Procedure

Intervention Name(s)

esophagectomy

Intervention Description

McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 6-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.

Primary Outcome Measure Information:

Title

Overall survival

Description

Time Frame

At end of enrollment- up to 5 years in follow up

Secondary Outcome Measure Information:

Title

Progression free survival

Description

Progression free survival is defined as the time from randomization until objective tumor progression or death.

Time Frame

At end of enrollment- up to 5 years in follow up

Title

Pathologic complete response rate

Description

No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes

Time Frame

Two weeks after surgery

Title

R0 resection rate

Description

The percentage of patients who undergo complete resection

Time Frame

Two weeks after surgery

Title

Incidence of perioperative complications

Description

Incidence of complications

Time Frame

Ninety days after surgery

Title

Perioperative mortality

Description

Incidence of death postoperatively

Time Frame

Ninety after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable. Patients must not have received any prior anticancer therapy. More than 6 months of expected survival. Age ranges from 18 to 70 years. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney. WHO PS score 0-1 Signed informed consent document on file. Exclusion Criteria: Patients have received any prior anticancer therapy. Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin. Patients with concomitant hemorrhagic disease. Patients who cannot tolerate surgery. Pregnant or breast feeding. Patients without informed consent because of psychological, family, social or any other factors. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more. Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer. Patients with history of diabetes over 10 years and unsatisfactory glycemic control. Patients with severe heart,lung,liver,renal dysfunction, hematopoietic system diseases, immune system diseases, cachexia or other diseases that lead to intolerance of chemoradiotherapy or surgery. Patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation. Patients with history of interstitial lung disease or noninfectious pneumonia. Patients with active pulmonary tuberculosis infection, or a history of active pulmonary tuberculosis infection within one year before enrollment, or a history of active pulmonary tuberculosis infection more than one year ago without regular treatment. Patients with active hepatitis B ( HBV DNA ≥ 2000 IU / mL or 104 copies / mL ) or hepatitis C ( HCV antibody positive ).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

HONG YANG, M.D. Ph.D.

Phone

8602087343

Ext

8602087343

yanghong@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

HONG YANG

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hong Yang, Ph.D.,M.D.

Phone

008613560405144

yanghong@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Jiyang Chen

Phone

008618826238208

chenjy1@sysucc.org.cn

12. IPD Sharing Statement

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PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC

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