A Real-World Study of Neoadjuvant/Conversion Therapy for Locally Advanced or Metastatic Gastric Cancer

NCT06464601 | Not Yet Recruiting

• 1 other identifier: HMPL-013-C2-GC02
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Chemotherapy, immune checkpoint inhibitors, and anti-angiogenic targeted therapies have been explored in combination for neoadjuvant and conversion therapies. However, the efficacy of the novel anti-angiogenic agent fruquintinib in combination with immune checkpoint inhibitors and chemotherapy in the neoadjuvant and conversion treatment of locally advanced or metastatic gastric cancer has not been reported. This study aims to observe the efficacy and safety of fruquintinib combined with immune checkpoint inhibitors and chemotherapy in real-world settings.

Conditions

Gastric Cancer

Keywords

fruquintinib; anti-angiogenic targeted therapies; neoadjuvant treatment; conversion treatment; gastric cancer

Outcome Measures

Primary Outcomes (2)

• Corhot1: Pathological Complete Response Rate (pCR)

  Pathological Complete Response Rate (pCR), defined as no residual tumor cells in the surgical specimen of the primary tumor and lymph nodes (ypT0N0); corresponds to TRG grade 0.

  Time from the first treatment up to 12 weeks

• Corhot2: R0 surgical conversion rate

  R0 surgical conversion rate：The proportion of subjects who achieve complete R0 resection of both the primary gastric lesion and any metastases among all subjects receiving the conversion therapy regimen.

  Time from the first treatment up to 24 weeks

Secondary Outcomes (10)

• Corhot1: R0 resection rate

  Time from the first treatment up to 12 weeks

• Corhot1: Event-Free Survival (EFS)

  Time from the first treatment up to 2 years.

• Corhot1: 1-year Event-Free Survival (EFS) rate

  Time from the first treatment up to 12 months.

• Corhot1 and Corhot2: Overall Survival (OS)

  Time from the first treatment up to 2 years.

• Corhot1 and Corhot2: 1-year Overall Survival (OS) rate

  Time from the first treatment up to 12 months.

Study Arms (2)

Cohort 1:neoadjuvant treatment

Combination Product: fruquintinib combined with immune checkpoint inhibitors and chemotherapy

Cohort 2:conversion treatment

Combination Product: fruquintinib combined with immune checkpoint inhibitors and chemotherapy

Interventions

fruquintinib combined with immune checkpoint inhibitors and chemotherapy COMBINATION_PRODUCT

Chemotherapy Drugs: Selection based on clinical guidelines/indications and patient condition.For example, recommended chemotherapy regimens: XELOX or SOX. Immune Checkpoint Inhibitors: Selection based on clinical guidelines/indications and patient condition, including but not limited to PD-1 inhibitors, PD-L1 inhibitors. Fruquintinib: 3mg (starting dose), PO (once daily). Dosing schedule and dosage can be adjusted based on concurrent chemotherapy and immune checkpoint inhibitors. Have received fruquintinib treatment for at least 2 cycles.

Cohort 1:neoadjuvant treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Histologically confirmed gastric or gastroesophageal junction adenocarcinoma. For neoadjuvant therapy cohort: candidates for Initial potentially curative surgery with cII, cIII, or cIVA stage disease (\>cT2N0-3M0 or cT0-4N+M0); no distant metastasis. For conversion therapy cohort: patients with locally advanced unresectable or stage IV metastatic disease (per AJCC 8th edition).

You may qualify if:

• Patients must meet all of the following criteria to be enrolled in this study:
• Age ≥18 years and ≤75 years;
• Either gender;
• Histologically confirmed gastric or gastroesophageal junction adenocarcinoma. For neoadjuvant therapy cohort: candidates for Initial potentially curative surgery with cII, cIII, or cIVA stage disease (\>cT2N0-3M0 or cT0-4N+M0); no distant metastasis. For conversion therapy cohort: patients with locally advanced unresectable or stage IV metastatic disease (per AJCC 8th edition). Pre-treatment imaging (CT or MRI, PET-CT, etc.) must indicate only one of the following unresectable factors:
• (1) Lymph node metastasis around the abdominal aorta (2) Virchow lymph node metastasis (left supraclavicular lymph node metastasis) (3) Resectable liver metastases: 2 to 5 metastatic lesions, total diameter \>5 cm and ≤8 cm, tumor invades the vena cava or portal vein (4) Lung metastases (5) Isolated peritoneal implantation
• \. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 before treatment.
• \. Expected survival time of \>6 months before neoadjuvant therapy and \>3 months before conversion therapy.
• \. No significant organ dysfunction or drug contraindications before receiving neoadjuvant or conversion therapy.
• \. There is no mandatory requirement for target lesions. Objective response rate (ORR) assessment is based on all evaluable patients, regardless of the presence of target lesions. For patients without target lesions, those assessed as non PR/non PD will be analyzed as stable disease (SD).

You may not qualify if:

• Patients meeting any of the following criteria are not eligible to enter the study:
• History of other primary malignant tumors, except: (1) complete remission of malignant tumors at least 2 years before enrollment and no need for other treatment during the study period; (2) adequately treated non-melanoma skin cancer or malignant melanoma without evidence of disease recurrence; (3) adequately treated in situ carcinoma.
• Conversion therapy cohort: Diagnosis of HER2-positive gastric or gastroesophageal junction adenocarcinoma.
• Female patients who are pregnant or lactating.
• Known allergy (Grade 3 or higher allergic reaction) or contraindication to anti-angiogenic drugs, any monoclonal antibody, or chemotherapy drug components.
• Use of non-study drug treatments during the study period that may interfere with the analysis.
• Patients who did not undergo any tumor efficacy assessment after receiving neoadjuvant or conversion therapy.
• Less than 2 cycles of fruquintinib neoadjuvant or conversion therapy.
• Patients with insufficient follow-up information as judged by the investigator (such as not returning to the hospital for treatment or efficacy assessment after initial treatment).

Sponsors & Collaborators

• Wuhan University: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Immune Checkpoint Inhibitors; Drug Therapy

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; Therapeutics

Study Officials

• Bin Xiong, doctor

  Zhongnan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ChunWei Peng, doctor

CONTACT

13476196566; whupengcw@whu.edu.cn

Bin Xiong, doctor

CONTACT

13886029351; binxiong1961@whu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 18, 2024
• Study Start: April 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)