PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy in Subjects With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

NCT05007145 | Unknown Phase 2

• 1 other identifier: OBU-FJ-EC-II-007
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to explore the efficacy and safety of compare the efficacy and safety of PD-1 inhibitor and chemotherapy（treatment group） with chemoradiotherapy（control group） in neoadjuvant treatment of resectable thoracic esophageal squamous cell carcinoma.

Conditions

Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma

Keywords

Neoadjuvant; Esophageal Cancer; PD-1 Inhibitor

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response (pCR) rate

  Within 14 working days after surgery

Secondary Outcomes (3)

• R0 resection rate

  Within 14 working days after surgery

• Overall Survival (OS)

  Up to 8 years

• Disease Free Survival (DFS)

  Up to 8 years

Study Arms (2)

PD-1 Inhibitor+albumin-bound paclitaxel+cisplatin

EXPERIMENTAL

Participants receive PD-1 Inhibitor 200mg on Day 1 every 3 weeks (Q3W), albumin-bound paclitaxel 125 mg/m\^2 on Day 1, 8 Q3W, and cisplatin 75 mg/m\^2 on Day 1 Q3W, a total of 2-4 cycles，followed by surgery.

Drug: PD-1 inhibitor; Drug: Albumin-Bound Paclitaxel; Drug: Cisplatin

Albumin-bound paclitaxel+cisplatin+radiotherapy

ACTIVE COMPARATOR

Participants receive albumin-bound paclitaxel 125 mg/m\^2 on Day 1, 8 Q3W, and cisplatin 75 mg/m\^2 on Day 1 Q3W, a total of 2 cycles combined with radiotherapy(40Gy/2Gy),followed by surgery.

Drug: Albumin-Bound Paclitaxel; Drug: Cisplatin; Radiation: Radiation

Interventions

PD-1 inhibitor DRUG

PD-1 Inhibitor 200mg D1 Q3W

PD-1 Inhibitor+albumin-bound paclitaxel+cisplatin

Albumin-Bound Paclitaxel DRUG

125 mg/m\^2 D1/D8 Q3W

Albumin-bound paclitaxel+cisplatin+radiotherapy; PD-1 Inhibitor+albumin-bound paclitaxel+cisplatin

Cisplatin DRUG

75 mg/m\^2 D1 Q3W

Albumin-bound paclitaxel+cisplatin+radiotherapy; PD-1 Inhibitor+albumin-bound paclitaxel+cisplatin

Radiation RADIATION

40Gy/2.0Gy

Albumin-bound paclitaxel+cisplatin+radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteered to participate in the study, signed the informed consent form;
• Histologically or cytological confirmed esophageal squamous cell carcinoma;
• Patients with resectable disease of primary tumor in thoracic esophagus (cT1b-4aN1-3M0, cT3-4aN0M0) evaluated by CT/MRI/EUS;
• Expected R0 resection;
• Aged 18-75 years, male or female;
• ECOG PS 0-1;
• Without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment for esophageal cancer;
• Surgery is planned after neoadjuvant treatment;
• Without any contraindication of operation;
• Adequate organ function as follows: 1) Routine blood test: Leukocytes \>=3.0x10\^9/L; Absolute neutrophil count \>=1.0x10\^9/L; Platelet \>=80x10\^9/L; Hemoglobin \>=90 g/L; 2) Blood biochemical test: Total bilirubin \<=1.5 ULN; ALT \<=2.5 ULN; AST \<=2.5 ULN; Serum creatinine \<=1.5 ULN or creatinine clearance rate \>=50 mL/min (Cocheroft-Gault); 3) Coagulation function test: INR \<=1.5 ULN; APTT \<=1.5 ULN;
• For females of child bearing potential, a negative serum/urine pregnancy test result within 72h before study treatment. For female and male participants of reproductive potential must be willing to use adequate contraception for the course of the study until 3 months after the last dose of any of the drugs in the study;
• Had good compliance and cooperated with the follow-up.

You may not qualify if:

• The tumor invades the adjacent organs of the esophageal lesion (aorta or trachea);
• Patients with supraclavicular lymph node metastasis;
• Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
• Poor nutritional status, BMI \< 18.5 Kg/m2; If corrected after nutritional support before randomization, enrollment can be further considered after evaluation by the principal investigator;
• Has a history of allergy to monoclonal antibody, any component of PD-1 Inhibitor, paclitaxel, cisplatin or other platinum drugs;
• Has received or is receiving any of the following treatments: A)any anti-tumor radiation, chemotherapy or other treatment drugs; B) Immunosuppressive drugs or whole-body hormone drugs are being used for immunosuppressive purposes within 2 weeks prior to the first use of the study drug (dose \> 10mg/ day prednisone or equivalent dose);Inhalation or topical use of steroids and 10 mg/ day prednisone or equivalent dose of adrenocortical hormone replacement is permitted in the absence of active autoimmune disease; C) Received attenuated vaccine within 4 weeks before the first use of the study drug; D) Major surgery or severe trauma within 4 weeks prior to the first use of the study drug;
• History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation;
• Present of poorly controlled cardiac symptoms or disease, including but not limited to: (1) heart failure with NYHA class II or above (2) unstable angina, （3）myocardial infarction occurred within 1 year (4) clinical significance supraventricular or ventricular arrhythmias without clinical intervention or poorly controlled after clinical intervention;
• Severe infection (CTCAE \> 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, infection complications requiring hospitalization, etc.;Baseline chest imaging indicated active pulmonary inflammation, infection signs and symptoms within 14 days prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except prophylactic antibiotic usage;
• Patients who are found to have active pulmonary tuberculosis infection through medical history or CT, or have active pulmonary tuberculosis infection history within 1 year before enrollment, or have active pulmonary tuberculosis infection history more than 1 year before but without regular treatment;
• Have hereditary bleeding tendency or coagulation dysfunction. There were clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood++ and above at baseline;
• Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10\^4 copies/mL), hepatitis C (HCV antibody positive, and HCV RNA higher than the detection limit of analytical method);
• Other malignancies diagnosed within 5 years prior to the first use of the study drug, except those with a low risk of metastasis or death (5-year survival rate \> 90%), such as adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix;
• Pregnant or lactating women;
• In the investigator's judgment, there were other factors that might have contributed to the forced termination of the study, such as the need for combined treatment with other serious medical conditions (including mental illness), alcohol and drug abuse, family or social factors that might have affected the safety or compliance of the subjects.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead
• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: collaborator

Study Sites (6)

Fujian Cancer Hospital

Fuzhou, Fujian, China

RECRUITING

the Second Hospital of Longyan

Longyan, Fujian, China

NOT YET RECRUITING

the First Hospital of Putian City

Putian, Fujian, China

NOT YET RECRUITING

Fujian Medical University 2nd Affiliated Hospital

Quanzhou, Fujian, China

NOT YET RECRUITING

Quanzhou First Hospital

Quanzhou, Fujian, China

NOT YET RECRUITING

the First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

NOT YET RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma

Interventions

Immune Checkpoint Inhibitors; Albumin-Bound Paclitaxel; Cisplatin; Radiation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Physical Phenomena

Study Officials

• Shuoyan Liu

  Fujian Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Shuoyan Liu

CONTACT

+86 13805088816; shuoyanliu2010@163.com

Study Design

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

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 16, 2021
• Study Start: August 15, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: December 21, 2021

Record last verified: 2021-11

Locations

CN (6)