A Study of Perioperative Camrelizumab Combined With Chemotherapy in Patients With Resectable ESCC

NCT05182944 | Recruiting Phase 2

• 1 other identifier: L2021-Y346-002
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell.

Conditions

Esophageal Cancer

Keywords

ESCC, perioperative, immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (2)

• Pathologic complete response，pCR

  defined as the absence of any viable tumor at the time of surgical resection, as assessed by central and local pathology laboratory

  At time of surgery

• 3 years disease free survival, DFS

  Time after R0 resection to disease recurrence or death

  up to 3 year

Secondary Outcomes (5)

• Major pathological response（MPR）

  At time of surgery

• Objective Response Rate (ORR)

  up to 2 year

• Disease-Free Survival (DFS)

  up to 5 year

• Overall Survival (OS)

  up to 5 year

• European Organisation for Research and Treatment of Cancer （EORTC） Multi-trait scaling analyses and face validity refined the module to four scales and six single items (QLQ-OES18).

  up to 5 year

Other Outcomes (1)

• The exploration of biomarkers

  up to 2 year

Study Arms (4)

After 2 cycles of neoadjuvant therapy,non-pCR patients adjuvant treatment

EXPERIMENTAL

After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, non-pCR patients adjuvant treatment（2-4 cycles Camrelizumab+Albumin Paclitaxel +Cisplatin and Camrelizumab maintenance treatment）

Drug: A：non-pCR patients

non-pCR patients adjuvant treatment

ACTIVE COMPARATOR

After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, non-pCR patients adjuvant treatment（Camrelizumab maintenance treatment）

Drug: B：non-pCR patients

pCR patients adjuvant treatment

EXPERIMENTAL

After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, pCR patients adjuvant treatment（Camrelizumab maintenance treatment）

Drug: A：pCR patients

pCR patients adjuvant treatment(BSC)

ACTIVE COMPARATOR

After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, pCR patients adjuvant treatment（Best Supportive Care）

Drug: B：pCR patients

Interventions

A：non-pCR patients DRUG

After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, non-pCR patients adjuvant treatment（2-4 cycles Camrelizumab+Albumin Paclitaxel+Cisplatin and Camrelizumab maintenance treatment） Camrelizumab, 200 mg，Intravenous injection，q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication

After 2 cycles of neoadjuvant therapy,non-pCR patients adjuvant treatment

B：non-pCR patients DRUG

After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, non-pCR patients adjuvant treatment（Camrelizumab maintenance treatment） Camrelizumab, 200 mg，Intravenous injection，q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication

non-pCR patients adjuvant treatment

A：pCR patients DRUG

After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, pCR patients adjuvant treatment（Camrelizumab maintenance treatment） Camrelizumab, 200 mg，Intravenous injection，q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication

pCR patients adjuvant treatment

B：pCR patients DRUG

After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, pCR patients adjuvant treatment（Best Supportive Care） Camrelizumab, 200 mg，Intravenous injection，q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication

pCR patients adjuvant treatment(BSC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-80 years, males or females；
• Histologically or cytologically confirmed as ESCC；
• Esophageal squamous cell carcinoma without anti-tumor treatment, and the clinical stage is T1b-2N+M0 or T3-4aN+/-M0 (AJCC/UICC TNM staging system 8th edition);
• It can provide tumor tissue for the detection of PD-L1 expression level;
• Follow-up surgery plan: radical esophageal squamous cell carcinoma surgery with esophagogastric reconstruction combined with at least complete 2 field lymph node dissection;
• ECOG: 0\~1;
• Expected survival time ≥ 12 weeks;
• Body mass index (BMI) ≥ 18.5kg/m2 or pg-sga score A / B;
• ）White blood cell count (WBC) ≥3.0 × 109/L, absolute neutrophil count (ANC) ≥1.5 × 109/L, platelet (PLT) count ≥100×109/L, hemoglobin (HGB) ≥90 g/L, No blood transfusion or other hematopoietic factor treatment for the previous 14 days； 2）Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤2.5×upper limit of normal (ULN); serum total bilirubin (TBIL) ≤1.5×ULN ; Albumin (ALB) ≥30g/L; 3）Serum creatinine (CRE)≤1.0×ULN, creatinine clearance (Ccr)≥60 mL/min (Cockcroft-Gault formula); 4）International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) ≤ 1.5 × ULN;
• Important organ functions: a) Heart function: normal or grade I; b) Lung function: FEV1\>1.2L, FEV1% \>40%; c) Liver function: Child-Pugh grade 5-6 points;
• For premenopausal women (postmenopausal women must have been postmenopausal for at least 12 months to be considered infertile), the serum pregnancy test result is negative. Male subjects (including male subjects' female spouses of childbearing age) and female subjects of childbearing age must contraception from the first study drug administration to 6 months after the last study drug administration；
• Obtain the informed consent signed by the subject or his legal representative;
• Can cooperate to complete research procedures and follow-up inspections。

You may not qualify if:

• Cervical esophageal squamous cell carcinoma;
• Combined with cervical, supraclavicular, abdominal, retroperitoneal and pelvic lymph node metastasis (except pericardial lymph node metastasis and left gastric lymph node metastasis);
• Previously received anti-tumor therapy for the primary disease (including surgery, chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy, radiotherapy, radiofrequency ablation, etc.) and other research treatments, except for Chinese patent medicines or Chinese herbal medicines stopped for more than 7 days ；
• Previously received anti-tumor therapy for the primary disease (including surgery, chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy, radiotherapy, radiofrequency ablation, etc.) and other research treatments, except for Chinese patent medicines or Chinese herbal medicines stopped for more than 7 days ；
• Previously active, potentially relapsed or undiagnosed autoimmune diseases, skin diseases (vitiligo, psoriasis, alopecia) without systemic treatment, well controlled type I diabetes, hypothyroidism (only thyroid hormone replacement therapy), and other diseases that were not expected to relapse under external stimulation were included.
• History of allogeneic stem cell transplantation or organ transplantation;
• Complicated with interstitial pneumonia or interstitial lung disease, non infectious pneumonia;
• History of gastrointestinal perforation and/or fistula, abdominal abscess, visceral fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive within 6 months before the first study drug administration bowel resection (including partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea;
• Major operations (except puncture and biopsy) or major trauma were performed ≤ 28 days before the administration of the first study drug;
• Have vaccinated or plan to vaccinate live vaccine within 28 days before the first study drug administration;
• Use corticosteroids (\>10 mg/day prednisone or equivalent dose) or other immunosuppressive agents within 14 days before the first study drug administration. Inhalation, ophthalmic, intra-articular, intranasal or topical corticosteroids can be used prophylactically for short-term (≤7 days) use of corticosteroids (for example, to prevent allergy to contrast agents) or for the treatment of non-autoimmune conditions (for example, delayed hypersensitivity caused by contact with allergens)
• Infectious diseases that affect activities of daily living or require systemic treatment (such as the use of hormones, antibiotics, antifungal drugs, antiviral drugs, and oxygen inhalation) within 14 days before the first study drug administration, including but not limited to the need Hospitalized infections, bacteremia, severe pneumonia, etc.;
• Combined with the following diseases that have not been well controlled, such as: a) New York Heart Association (NYHA) ≥ Grade 2 heart failure, b) Severe/Unstable Angina, c) Myocardial infarction ≤ 6 months before study administration, d) Severe arrhythmia requiring medication or intervention, e) Uncontrollable hypertension, f) Occurrence/combined arterial and/or venous thromboembolism ≤2 months before the first study administration, g) ≤6 before the first study administration A cerebrovascular accident occurred within a month, h) diabetes that has not been effectively controlled, i) thyroid disease that has not been effectively controlled, j) urine protein ≥ 2+ and 24-hour urine protein quantification ≥ 1.0g;
• Tuberculosis (TB) who has received anti-tuberculosis treatment within 1 year before receiving/receiving/first study administration;
• Human immunodeficiency virus infection (HIV1/2 antibody positive);

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Song Zhao

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Song Zhao

CONTACT

13673665008; zhaosong@zzu.cn

Yu Qi

CONTACT

13803892392; qiyu@zzu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 10, 2022
• Study Start: January 15, 2022
• Primary Completion: January 15, 2024
• Study Completion (Estimated): January 15, 2027
• Last Updated: May 11, 2022

Record last verified: 2021-11

Locations

CN (1)