Efficacy and Safety of Anlotinib Hydrochloride Combined With Nivolumab in the Treatment of Gastric and Esophageal Cancer

NCT04503967 | Unknown Phase 2 DMC

• 1 other identifier: OASIS
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with unresectable or metastatic gastric or esophageal cancer, with first-line treatment applied are to be recruited in the study. In the current study, the efficacy and safety of anlotinib hydrochloride combined with nivolumab as second-line or salvage chemotherapy will be evaluated in Chinese patients with advanced gastric adenocarcinoma and esophageal squamous cell carcinoma. 48 patients could provide adequate precision rather than controlling type I\&II error.

Conditions

Gastric Adenocarcinoma; Esophageal Squamous Cell Carcinoma

Keywords

Gastric Cancer; esophageal cancer; Anlotinib Hydrochloride; Nivolumab

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  The ORR in patients with unresectable or metastatic GC or ESCC patients treated with anlotinib hydrochloride in combination with nivolumab as a second-line or later treatment.

  up to 2 years

Secondary Outcomes (2)

• Progression-free survival

  up to 2 years

• Overall survival

  up to 2 years

Study Arms (1)

Anlotinib Hydrochloride With Nivolumab

EXPERIMENTAL

Anlotinib Hydrochloride Combined With Nivolumab in the second line treatment of Gastric and Esophageal Cancer patients

Drug: Anlotinib Hydrochloride With Nivolumab

Interventions

Anlotinib Hydrochloride With Nivolumab DRUG

Anlotinib Hydrochloride Combined With Nivolumab in the second line Treatment of Gastric and Esophageal Cancer patients

Anlotinib Hydrochloride With Nivolumab

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient volunteers to participate in the study, signs a consent form, has good compliance, and obeys the follow-up, and is willing and able to follow the protocol during the study.
• Male or female, aged ≥18 years and ≤75 years.
• The ECOG PS score is 0 or 1.
• Histological and/or cytological confirmation of patients with unresectable or metastatic gastric adenocarcinoma or esophageal squamous cell carcinoma.
• Patients have failed previous first-line standard treatments, have measurable target lesions, and have not received local treatments such as radiotherapy for target lesions (Note: lesions that have previously received radiation therapy cannot be considered target lesions, except that after radiation therapy, clear progress has occurred).
• At least 4 weeks after previous major surgical and / or radiation therapy (at least 2 weeks after palliative radiotherapy).
• The use of 0-1 antihypertensive drug can effectively control blood pressure, which is defined as random pre-systolic blood pressure ≤140mmHg, diastolic blood pressure ≤90mmHg, and no antihypertensive drug has been changed within one week before randomization.
• Appropriate bone marrow reserve, as shown in the blood count of the subject within 7 days before enrollment: hemoglobin ≥90g / L; ANC ≥1.5 × 109 / L; platelet ≥90 × 109 / L (patients have not received blood transfusion or growth factor support within 2 weeks prior blood collection).
• Appropriate liver function is shown to meet all of the following requirements:
• Serum total bilirubin ≤ 1.5 x ULN (Gilbert syndrome patients can be included if the total bilirubin is \<3 x ULN, and those with biliary obstruction allow biliary drainage);
• serum albumin ≥30g / L;
• AST, ALT ≤ 3 x ULN (If liver metastases exist, AST and ALT allow ≤ 5 x ULN).
• Appropriate renal function demonstrated by all of the following requirements:
• Serum creatinine ≤ 1.5 x ULN and creatinine clearance ≥ 50ml/min (using Cockcroft-Gault formula);
• Proteinuria \<++; if proteinuria is ≥++, 24-hour urine protein must be \<2g.

You may not qualify if:

• Have undifferentiated or other histological types of gastric or esophageal cancer; evidence of tumor invasion of major blood vessels (including completely adjacent, surrounding, or extending into the main vessel lumen, such as the pulmonary artery or superior vena cava) , and the researcher judges that it is not suitable for enrollment.
• Patients with active autoimmune disease or a history of autoimmune disease but who may relapse.
• Note: Patients with the following diseases are not excluded and can be entered for further screening:
• Controlled Type 1 Diabetes
• Hypothyroidism (if only controlled by hormone replacement therapy)
• Controlled celiac disease
• Skin diseases that do not require systemic treatment (e.g. vitiligo, psoriasis, hair loss)
• Any other disease that is not expected to recur without external triggers
• Any active malignant tumor within 2 years, except for the specific cancer being studied in this trial and cured local recurrent cancer (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ).
• There is uncontrollable pleural effusion, pericardial effusion, or ascites that need to be drained frequently within 7 days before enrollment (allow effusion cytology to confirm).
• Gastrointestinal perforation and / or fistula occurred within 6 months before enrollment.
• There are many factors that affect oral drug absorption (such as inability to swallow, nausea and vomiting, upper gastrointestinal obstruction, abnormal physiological function, malabsorption syndrome, etc.), which may affect anlotinib hydrochloride absorbers.
• Weight loss ≥ 20% within 2 months before enrollment.
• History of the following diseases: interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.
• Severe chronic or active infections, including tuberculosis, that require systemic antibacterial, antifungal or antiviral treatment.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Related Publications (1)

• Wu J, Zhang S, Yu S, An G, Wang Y, Yu Y, Liang L, Wang Y, Xu X, Xiong Y, Shao D, Shi Z, Li N, Wang J, Jin D, Liu T, Cui Y. Nivolumab plus anlotinib hydrochloride in advanced gastric adenocarcinoma and esophageal squamous cell carcinoma: the phase II OASIS trial. Nat Commun. 2024 Oct 15;15(1):8876. doi: 10.1038/s41467-024-53109-4.

  PMID: 39406730 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Stomach Neoplasms; Esophageal Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 7, 2020
• Study Start: August 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 7, 2020

Record last verified: 2020-08