TQB2450 Plus Anlotinib Combined With Chemotherapy in the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma

NCT04891900 | Active Not Recruiting

• 1 other identifier: 2021-054-003
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective one arm phase II clinical study to evaluate the efficacy and safety of TQB2450 (PD-L1 inhibitor), anlotinib combined with oxaliplatin and capecitabine in patients with unresectable locally advanced, recurrent or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction.

Conditions

Gastric Cancer; Adenocarcinoma of Esophagogastric Junction

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  each 2 weeks(Initial treatment) or 3 weeks (maintenance treatment ) up to Progressive Disease（PD） or toxicity intolerable

Secondary Outcomes (3)

• Disease Control Rate (DCR)

  each 2 weeks(Initial treatment) or 3 weeks (maintenance treatment ) up to Progressive Disease（PD） or toxicity intolerable

• Duration of Progression-Free Survival (PFS)

  each 2 weeks(Initial treatment) or 3 weeks (maintenance treatment ) up to Progressive Disease（PD） or toxicity intolerable

• Duration of Overall Survival (OS)

  each 2 weeks(Initial treatment) or 3 weeks (maintenance treatment ) up to Progressive Disease（PD） or toxicity intolerable

Study Arms (1)

TQB2450 combined with anlotinib, oxaliplatin and capecitabine in the treatment of GC or AEG

EXPERIMENTAL

In this study, all subjects were treated with TQB2450 (PD-L1 inhibitor) plus anlotinib combined with oxaliplatin and capecitabine, once every 3 weeks, six cycles of chemotherapy with oxaliplatin and capecitabine. Subsequently, TQB2450 (PD-L1 inhibitor) combined with anlotinib was maintained until disease progression, intolerable toxicity, withdrawal of informed consent, loss of follow-up or death, or other circumstances that the researcher judged should stop treatment, whichever occurred first.

Drug: TQB2450/Anlotinib hydrochloride/Oxaliplatin/Capecitabine

Interventions

TQB2450/Anlotinib hydrochloride/Oxaliplatin/Capecitabine DRUG

Initial treatment (6 cycles)： 1. TQB2450：1200 mg , Day 1 ivgtt ,once every 3 weeks 2. Anlotinib: 10 mg/day orally ，from days 1 to 14 in a 21-day cycle 3. Oxaliplatin: 130 mg / m2, Day 1 ivgtt ,once every 3 weeks 4. Capecitabine: 1000 mg / m2, orally, twice a day (once in the morning and once in the evening), from days 1 to 14 in a 21-day cycle Maintenance treatment： 1）TQB2450: 1200 mg , Day 1 ivgtt , once every 3 weeks 2）Anlotinib: 10 mg/day orally , from days 1 to 14 in a 21-day cycle

Also known as: PD-L1 inhibitor/Anlotinib

TQB2450 combined with anlotinib, oxaliplatin and capecitabine in the treatment of GC or AEG

Eligibility Criteria

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

You may qualify if:

• Patients volunteered to participate in the study and signed the informed consent.
• Age 18-75, both male and female.
• Histology or cytology confirmed HER2/Neu negative (or HER2 / Neu status cannot be determined) non resectable locally advanced or metastatic gastric or esophageal union adenocarcinoma (including signet ring cell carcinoma, mucinous adenocarcinoma and hepatoid adenocarcinoma).
• The time from the end of previous (neoadjuvant) chemotherapy / adjuvant radiotherapy to recurrence was more than 6 months.
• At least one measurable lesion according to RECIST 1.1, which should not be received local treatment such as radiotherapy. If the lesions located in the previous radiotherapy area are confirmed to have progressed and meet the RECIST 1.1 standard, they can also be selected as target lesions.
• ECOG PS 0-1.
• Expected survival ≥ 3 months.
• Adequate organ function as indicated by the following screening laboratory values： Blood test criteria include：
• Hemoglobin content (HB) ≥ 90g / L (no blood transfusion within 14 days)
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
• Platelet count (PLT) ≥ 100 × 109/L (no use of IL-11 or TPO within 14 days)
• WBC ≥ 4.0 × 109/L (no granulocyte stimulating factor used within 14 days)
• Biochemical tests should meet the following standards:
• Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN)
• ALT and AST≤2.5ULN

You may not qualify if:

• Allergic to any test drug and its excipients, or with a history of severe allergy, or as a contraindication to the test drug.
• Active or history of autoimmune disease .
• Symptomatic / Asymptomatic brain metastases.
• CT suggests definite ulcerative lesions or stool occult blood positive.
• There was a history of abnormal bleeding one month before admission ( Except epistaxis ).
• Prior allogeneic bone marrow transplantation or organ transplantation
• Congenital pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia, or active pneumonia confirmed by CT.
• HIV positive, active hepatitis B or C, active tuberculosis.
• Uncontrolled cancer pain
• Live attenuated vaccine was injected 4 weeks before the start of the study, or is expected to be injected during the trial or within 5 months after the end of the trial.
• Have received PD-1 / PD-L1 antibody, CTLA-4 antibody, or other treatment for PD-1 / PD-L1 and / or VEGFR inhibitors, or have not recovered from adverse events caused by medication more than 4 weeks ago (i.e., have not recovered to ≤ level 1 or baseline level).
• Systemic application of glucocorticoids or immunosuppressants within 2 weeks before the start of the trial (Note: inhaled glucocorticoids and corticosteroids are allowed).
• Symptomatic central nervous system metastases and / or cancerous meningitis are known. Patients with a history of central nervous system metastasis or spinal cord compression can be enrolled if they have received definite treatment and have stable clinical manifestations 4 weeks after discontinuation of anticonvulsants and steroids before the first administration of the study.
• Hormone contraindications.
• Affect oral medications (e.g. inability to swallow, chronic diarrhea, intestinal obstruction, etc.).

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Related Publications (1)

• Bie L, Wei C, Luo S, Dong S, Gu Z, Ma Y, Xia Q, Zhang H, Li J, Deng W, Li N. Benmelstobart plus anlotinib and chemotherapy in HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma: A phase 2 study. Cell Rep Med. 2025 Jun 17;6(6):102145. doi: 10.1016/j.xcrm.2025.102145. Epub 2025 May 22.

  PMID: 40409264 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Immune Checkpoint Inhibitors; anlotinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Ning Li, Doctor

  Henan Tumor Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 19, 2021
• Study Start: May 10, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-05

Locations

CN (1)