Apatinib Plus Camrelizumab Combined With Docetaxel and S1 in First-line Treatment for Metastatic Gastric Cancer

NCT04781686 | Unknown Phase 2 DMC

• 1 other identifier: HCCSC G05
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Apatinib plus Camrelizumab combined with docetaxel and S-1 as the first-line treatment of metastatic adenocarcinoma of gastric and gastroesophageal junction.

Conditions

Metastatic Gastric Adenocarcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator

  36 months

Secondary Outcomes (4)

• objective response rate (ORR)

  36 months

• overall survival (OS)

  36 months

• disease control rate (DCR)

  36 months

• adverse events (AE)

  36 months

Study Arms (1)

First-line treatment

EXPERIMENTAL

First-line treatment: Apatinib plus Camrelizumab combined with Docetaxel and S1 for six cycles. Maintenance treatment: Apatinib and Camrelizumab

Drug: Camrelizumab; Drug: Apatinib Mesylate; Drug: S1; Drug: Docetaxel injection

Interventions

Camrelizumab DRUG

Camrelizumab (200mg) will be given i.v. on day 1 of each 3-week cycle

Also known as: SHR-1210

First-line treatment

Apatinib Mesylate DRUG

Apatinib (250mg) will be administered orally once a day .

First-line treatment

S1 DRUG

S1 (BSA\<1.25 40mg, BSA \>=1.25-\<1.5 50mg, BSA \>=1.5 60mg) will be administered orally twice daily on days 1-7 of each 3-week cycle

First-line treatment

Docetaxel injection DRUG

Docetaxel (75mg/m2 IV.drop) will be administered on day 1 of each 3-week cycle, for six cycles.

First-line treatment

Eligibility Criteria

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

You may qualify if:

• Aged between 18 and 75 years;
• Has histologically or cytologically diagnosed with unresectable locally advanced or metastatic gastric adenocarcinoma (GC) including gastroesophageal junction adenocarcinoma;
• Human epidermal growth factor receptor 2 (HER2) negative: immunohistochemical (IHC) - or +; IHC ++ and fluorescence in situ hybridization (FISH) -;
• No previous systemic therapy (chemotherapy, targeted therapy, immunotherapy, biological therapy, etc.) for GC/GEJ. Subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled. Anti-tumor traditional Chinese medicine is forbidden within 2 weeks before the first cycle chemotherapy. Patients are allowed to receive palliative radiotherapy (primary tumor or metastasis), but lesions in radiation field cannot be defined as target lesions for assessing objective response, and radiotherapy-related adverse reactions must be restored to at least grade 1；
• Expected survival time ≥ 3 months;
• Eastern Cooperative Group (ECOG) performance status score 0 or 1;
• Weight ≥40kg, or BMI\>18;
• measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST(Response Evaluation Criteria In Solid Tumors）1.1;

You may not qualify if:

• The main organ function of cases should be normal, and meet the following criteria:
• ① Absolute neutrophil count (ANC)≥1.5×109/L, platelet (PLT) ≥80×109/L;
• ② Total bilirubin (TBIL) \<1.5 upper limit of normal (ULN), ALT (glutamic-pyruvic transaminase）and AST(glutamic-oxalacetic transaminase)≤2.5ULN. For subjects with liver metastases, ALT and AST≤5 ULN, serum Cr≤1.5ULN or endogenous creatinine clearance \>50ml /min (Cockcroft-Gault formula);
• ③ International normalized ratio (INR) \<1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 ULN;
• ④ Urine protein\<2+; if urine protein≥2+, the 24-hour urine protein quantitative detection value must be ≤1g;
• Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and the results are negative, and willing to use appropriate contraception during the study period until at least 3 months after the last administration of the test drugs. Non-sterilized males who are sexually active must agree to use adequate contraception during the study period a until at least 3 months after the last administration of the test drugs;
• Fully understand the study and voluntarily sign the informed consent form (ICF); willing and able to comply with planned visits, treatments, laboratory examinations and other procedures.
• HER2 positive cancer: IHC+++, IHC++ and FISH+;
• Pathological classification of tumor is squamous carcinoma or undifferentiated carcinoma or other types;
• The interval between disease progression and previous anti-tumor therapy for locally advanced is less than six months;
• Central nervous system（CNS）metastases with clinical symptoms for example cerebral edema, spinal cord compression, cancerous meningitis, leptomeningeal disease, and/or progressive growth. For subjects with CNS metastases that have been adequately treated, and the neurological symptoms can return to baseline levels at least 2 weeks before enrollment (except for residual signs or symptoms related to treatment), can be enrolled. In addition, subjects must stop corticosteroids at least 2 weeks before enrollment;
• Gastrointestinal bleeding that could not be effectively controlled; gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment; arterial/venous thrombosis occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
• Pleural fluid, ascites, or pericardial effusion that could not be controlled within 7 days before enrollment;
• Weight loss is more than 20% within 2 months before enrollment;
• Major surgery performed within 28 days before enrollment (tissue biopsy for diagnosis and central venous catheter placement via peripheral vein are allowed). used immunosuppressive drugs within 7 days before enrollment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (≤10 mg/d prednisone or equivalent other kinds of corticosteroids);

Sponsors & Collaborators

• Zhou Fuxiang: lead
• Hubei Cancer Hospital: collaborator
• Henan Provincial People's Hospital: collaborator
• Huangshi Central Hospital: collaborator

Study Sites (1)

Zhongnan Hopital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

MeSH Terms

Interventions

camrelizumab; apatinib; S 1 (combination); Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Fuxiang Zhou, M.D.

CONTACT

+86-027-67813155; happyzhoufx@sina.com

Huangang Jiang, M.D.

CONTACT

+86-027-67813215; hgjiang@whu.edu.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 INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: May 14, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)