Phase II Clinical Study of Camrelizumab Combined With Chemotherapy or Anlotinib in Advanced Esophageal Squamous Cell Cancer

NCT05322499 | Unknown Phase 2

• 1 other identifier: IRB-2021-444
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To observe and evaluate the efficacy and safety of camrelizumab combined with chemotherapy or anlotinib in patients with advanced esophageal squamous cell carcinoma previously Treated With First-line Immunotherapy

Conditions

Stage IV Esophagus Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  Up to 24 month

Secondary Outcomes (4)

• Duration of response (DoR)

  Up to 24 month

• Disease control rate (DCR)

  Up to 24 month

• Progression-free survival (PFS)

  Up to 24 month

• Overall survival (OS)

  Up to 24 month

Study Arms (2)

Combined chemotherapy group

EXPERIMENTAL

Camrelizumab: Subjects were infused at a dose of 200 mg/time, D1, once every 3 weeks (q3w); Chemotherapy (considered by investigator on a patient-by-patient basis): Irinotecan: 100-125mg/m2, d1, d8; q21d; Paclitaxel: 135-175mg/m2, d1, Q3W; Docetaxel: 60-75mg/m2, d1, Q3W Albumin paclitaxel: 100-135mg/m2, d1, d8, Q3W. Treat until disease progression or intolerable toxicity

Drug: Camrelizumab; Drug: Irinotecan; Drug: Paclitaxel; Drug: Paclitaxel-albumin; Drug: Docetaxel

Combined anlotinib group

EXPERIMENTAL

Camrelizumab: Subjects were infused at a dose of 200 mg/time, D1, once every 3 weeks (q3w); Anlotinib: 12mg, qd, d1-d14, q3w; Treat until disease progression or intolerable toxicity.

Drug: Camrelizumab; Drug: Anlotinib

Interventions

Camrelizumab DRUG

200mg/dose intravenous infusion, D1, once every 3 weeks (q3w);

Also known as: SHR-1210

Combined anlotinib group; Combined chemotherapy group

Irinotecan DRUG

100-125mg/m2，d1，d8；q21d

Combined chemotherapy group

Paclitaxel DRUG

135-175mg/m2，d1，Q3W

Combined chemotherapy group

Paclitaxel-albumin DRUG

100-135mg/m2, d1、d8，Q3W

Combined chemotherapy group

Docetaxel DRUG

60-75mg/m2，d1，Q3W

Combined chemotherapy group

Anlotinib DRUG

12mg，qd，d1-d14，q3w

Combined anlotinib group

Eligibility Criteria

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

You may qualify if:

• Age 18-75 years old, male or female;
• Participants signed and dated written informed consent. (Informed consent forms must be signed prior to any protocol-related procedures that are not part of the participant's routine medical care.);
• Patients with advanced esophageal squamous cell carcinoma diagnosed as stage IV by histopathology or cytology;
• ECOG PS score of physical condition: 0-1 points;
• Expected survival period ≥ 3 months;
• Patients with esophageal squamous cell carcinoma who have received first-line or above systemic therapy in the past, and who have received at least 2 times of PD-1 immunotherapy;
• Laboratory inspection indicators meet the following requirements:
• (1) Bone marrow function: hemoglobin (Hb) ≥ 90g/L; white blood cell count (WBC) ≥ lower limit of normal; absolute neutrophil value (ANC) ≥ 1.5×10\^9 /L; platelet count ≥ 100×10\^9 / L; (2) Renal function: Cr≤UNL (upper limit of normal)×1.5, endogenous creatinine clearance rate (Ccr)≥55 ml/min; (3) Liver function: total bilirubin≤ULN×1.5; ALT and AST≤ULN×2.5; (4) Coagulation function: the international normalized ratio of prothrombin time is less than or equal to ULN×1.5, and the partial thromboplastin time is within the normal range; 8. Females of childbearing age agree to contraception during the study period and within 6 months after the end of the study; serum or urine pregnancy test is negative within 7 days before the study is enrolled, and non-lactating patients; males agree to use contraception during the study period and within 6 months after the end of the study contraceptive patients; 9. Those who have not participated in clinical trials of other drugs within 4 weeks before enrollment; 10. Patients with good compliance are expected to be able to follow up the efficacy and adverse reactions according to the requirements of the program; 11. In view of the unclear definition of primary drug resistance and the lack of standard treatment options for such patients, there is a potential possibility of benefiting such patients with immunization combined with anti-angiogenesis or chemotherapy, but there is also a certain risk of hyperprogression; Therefore, for patients with possible primary drug resistance, they must be included in the group after evaluation by the investigator.

You may not qualify if:

• Other malignant tumors have been diagnosed in the past 5 years;
• Patients with active bleeding within two months of the primary tumor;
• Patients with severe adverse reactions related to immunotherapy after previous use of immunotherapy;
• Patients with any active autoimmune disease or autoimmune disease (including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vascular inflammation, glomerulonephritis, uveitis, hypophysitis, hyperthyroidism, etc.). Type 1 diabetes mellitus receiving stable doses of insulin, hypothyroidism receiving only hormone replacement therapy, no systemic therapy required, and no acute exacerbation of skin disease (eg, eczema, vitiligo, or psoriasis) within 1 year prior to the screening period. );
• Suffering from uncontrolled clinical symptoms or diseases of the heart;
• Active infection or fever (except for definite tumor fever);
• History or evidence of interstitial lung disease or active non-infectious pneumonia;
• Females of childbearing age agree to contraception during the study period and within 6 months after the end of the study; serum or urine pregnancy test is negative within 7 days before the study is enrolled, and non-lactating patients; males agree to use contraception during the study period and within 6 months after the end of the study contraceptive patients;
• Those who have not participated in clinical trials of other drugs within 4 weeks before enrollment;
• Patients with good compliance are expected to be able to follow up the efficacy and adverse reactions according to the requirements of the program;
• In view of the unclear definition of primary drug resistance and the lack of standard treatment options for such patients, there is a potential possibility of benefiting such patients with immunization combined with anti-angiogenesis or chemotherapy, but there is also a certain risk of hyperprogression; Therefore, for patients with possible primary drug resistance, they must be included in the group after evaluation by the investigator.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

camrelizumab; Irinotecan; Paclitaxel; Docetaxel; anlotinib

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)

Camptothecin; Alkaloids; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Xinmin Yu, Doctor

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinmin Yu, MD

CONTACT

13705718617; yuxm@zjcc.org.cn

Qiong He, MD

CONTACT

18267111327; 2005.hq@163.com

Study Design

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

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 11, 2022
• Study Start: April 15, 2022
• Primary Completion: April 15, 2023
• Study Completion: April 15, 2025
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)