A Study of Camrelizumab Combined With Chemotherapy as Neoadjuvant Therapy in Adcanced Esophageal Squamous Cell Carcinoma (ESCC)

NCT04767295 | Unknown Phase 2

• 1 other identifier: HNCH-ESCC-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and platinum chemotherapy in the preoperative treatment of locally advanced thoracic esophageal squamous cell carcinoma

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

PD-1 Checkpoint Inhibitor; Neoadjuvant Therapy; Esophageal Squamous Cell Carcinoma (ESCC)

Outcome Measures

Primary Outcomes (5)

• Objective remission rate (ORR)

  evaluated by researchers based on the RECIST 1.1 standard

  through study completion, an average of 2 year

• progression free survival (PFS)

  evaluated by researchers based on the RECIST 1.1 standard

  through study completion, an average of 2 year

• overall survival (OS)

  evaluated by researchers based on the RECIST 1.1 standard

  through study completion, an average of 2 year

• Disease control rate(DCR)

  evaluated by researchers based on the RECIST 1.1 standard

  through study completion, an average of 2 year

• pathologic complete response (pCR)

  evaluated by researchers based on the RECIST 1.1 standard

  through study completion, an average of 2 year

Study Arms (1)

Camrelizumab, Albumin Paclitaxel, Carboplatin

EXPERIMENTAL

ESCC participants in this study will be given intravenous administration of Camrelizumab (200mg/3w) combined with albumin paclitaxel (260 mg/m2) plus carboplatin chemotherapy. Every three weeks for a cycle of treatment, which will be conducted twice, and minimally invasive surgery within 5-8 weeks after the last administration. Treatments will be administrated until disease progression, unacceptable adverse events (AE), concomitant diseases that hinder continued treatment.

Drug: Camrelizumab, Albumin Paclitaxel, Carboplatin

Interventions

Camrelizumab, Albumin Paclitaxel, Carboplatin DRUG

Intravenous administration of Camrelizumab (200mg/3weeks); Intravenous administration of albumin paclitaxel (260 mg/m2/3weeks); Intravenous administration of carboplatin (AUC 4/3weeks)

Also known as: SHR1210

Camrelizumab, Albumin Paclitaxel, Carboplatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent form before any trial-related procedures are implemented;
• Age 18-70 years, both men and women;
• pathologically confirmed thoracic esophageal squamous cell carcinoma;
• The clinical staging is T3-4a (potentially resectable) N0-2 (PET/CT or cervical, chest and abdomen CT + intra-esophageal ultrasound staging, except those with N3 stage); T1-2N1-2 can be included in the study, T4b, T1-2N0, carcinoma in situ are all excluded;
• The longitudinal length of the tumor is less than 8cm;
• Patients can be followed up for a long time and cooperate with treatment;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; life expectancy\> 6 months;
• No other treatments including chemotherapy, radiotherapy, Chinese medicine treatment, etc. were used before selection.
• There is no history of radiotherapy in the chest cavity.
• Hematopoietic function is good before treatment, which is defined as absolute neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90g/L (No blood transfusion within 7 days or no erythropoietin (EPO) dependence);
• Liver function is good before treatment, defined as total bilirubin level ≤ upper normal limit (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 1.5 times ULN;
• Good renal function before treatment, defined as serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula); urine protein in routine examination of urine is less than 2+, or 24-hour urine Protein quantitative \<1g;
• Good coagulation function before treatment, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN; if the subject is receiving anticoagulation therapy, they can also be included in this trail as long as the PT is within the intended range of anticoagulation drugs;
• For female subjects of childbearing age, they should have a negative urine or serum pregnancy test within 3 days before receiving the first study drug administration (cycle 1, day 1). If the urine pregnancy test result cannot be confirmed as negative, blood pregnancy test is required. If there is a risk of conception, male and female patients need to use high-efficiency contraception (ie, a method with a failure rate of less than 1% per year) and continue until at least 180 days after stopping the trial treatment.

You may not qualify if:

• Medical history of malignant tumors in other parts, excluding curable non-melanoma skin cancer, radically excised cervical carcinoma in situ, and malignant tumors that have been cured for more than 5 years;
• Pregnant or breast-feeding patients who have fertility but have not taken contraceptive measures;
• Those who are allergic to the study drug camrelizumab, paclitaxel or platinum;
• Previous peripheral neuropathy (whether primary or secondary);
• Severe comorbidities: large-area myocardial infarction, myocardial infarction within 6 months, history of cerebral infarction, heart function ≥ grade III, history of mental illness and severe diabetes, severe pulmonary dysfunction, or other conditions that are not suitable for surgery;
• Participate in other clinical trials at present or within four weeks before being selected;
• Simultaneous treatment with other anti-cancer drugs (including anti-cancer Chinese medicine);
• Have a history of organ transplantation;
• Those who cannot cooperate because of dementia or mental disorders;
• Cachexia, weight loss over the past six months\> 10%;
• Histology contains non-squamous carcinoma components, such as small cell carcinoma, adenocarcinoma, etc.;
• Have received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or for another stimulating or synergistic inhibition of T cell receptors (for example, CTLA-4, OX-40, CD137) drug;
• Have received systemic treatment with anti-cancer indications Chinese patent medicines or immunomodulatory drugs (including thymosin, interferon, interleukin) within 2 weeks before the first administration, or received major surgical treatment within 3 weeks before the first administration; those with previous partial gastrectomy, bowel surgery history, or those who are not suitable for minimally invasive surgery are excluded from the group;
• There is clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction; received solid organ or blood system transplantation;
• Active autoimmune diseases that require systemic treatment (such as the use of disease-relieving drugs, corticosteroids, or immunosuppressants) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;

Sponsors & Collaborators

• Hunan Cancer Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Wenxiang Wang

Changsha, Hunan, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

camrelizumab; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• wangwenxiang@hnca.org.cn wangwenxiang@hnca.org.cn

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenxiang Wang

CONTACT

+8613808454225; wangwenxiang@hnca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients fulfilling Eligibility Criteria will be included in our study. ESCC participants in this study will be given intravenous administration of SHR-1210 (200mg/3w) combined with albumin paclitaxel (260 mg/m2) plus carboplatin chemotherapy. Every three weeks for a cycle of treatment, which will be conducted twice, and minimally invasive surgery within 5-8 weeks after the last administration. Treatments will be administrated until disease progression, unacceptable adverse events (AE), concomitant diseases that hinder continued treatment.

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: February 23, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: please contact the principal investigator of this study or correspondence author of published work

Locations

CN (1)