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

NCT ID: NCT06464601

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-03-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cohort 1:neoadjuvant treatment

fruquintinib combined with immune checkpoint inhibitors and chemotherapy

Intervention Type: 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 2:conversion treatment

fruquintinib combined with immune checkpoint inhibitors and chemotherapy

Intervention Type: 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.

Interventions

fruquintinib combined with immune checkpoint inhibitors and chemotherapy

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.

Intervention Type: COMBINATION_PRODUCT

fruquintinib combined with immune checkpoint inhibitors and chemotherapy

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

Patients must meet all of the following criteria to be enrolled in this study:

1. Age ≥18 years and ≤75 years;

2. Either gender;

3. 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

4. Have received chemotherapy, immune checkpoint inhibitors, and fruquintinib for at least 2 cycles. For the neoadjuvant therapy cohort, patients who have not previously received anticancer treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy, etc.). The patients are eligible for inclusion in the analysis set if they have received fruquintinib treatment for at least 2 cycles and have undergone at least one baseline tumor assessment. All patients included in the efficacy analysis are included in the safety analysis set.

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 before treatment.

6. Expected survival time of >6 months before neoadjuvant therapy and >3 months before conversion therapy.

7. No significant organ dysfunction or drug contraindications before receiving neoadjuvant or conversion therapy.

8. 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).

4. Female patients who are pregnant or lactating.

5. Known allergy (Grade 3 or higher allergic reaction) or contraindication to anti-angiogenic drugs, any monoclonal antibody, or chemotherapy drug components.

6. Use of non-study drug treatments during the study period that may interfere with the analysis.

7. Patients who did not undergo any tumor efficacy assessment after receiving neoadjuvant or conversion therapy.

8. Less than 2 cycles of fruquintinib neoadjuvant or conversion therapy.

9. 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).

Exclusion Criteria

Patients meeting any of the following criteria are not eligible to enter the study:

1. 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.

2. Conversion therapy cohort: Diagnosis of HER2-positive gastric or gastroesophageal junction adenocarcinoma.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Bin Xiong, MD

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bin Xiong, doctor

Role: PRINCIPAL_INVESTIGATOR

Zhongnan Hospital

Locations

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Countries

China

Central Contacts

ChunWei Peng, doctor

Role: CONTACT

whupengcw@whu.edu.cn

13476196566

Bin Xiong, doctor

Role: CONTACT

binxiong1961@whu.edu.cn

13886029351

Facility Contacts

ChunWei Peng, doctor

Role: primary

whupengcw@whu.edu.cn

134 7619 6566

Bin Xiong, doctor

Role: backup

binxiong1961@whu.edu.cn

138 8602 9351

Other Identifiers

HMPL-013-C2-GC02

Identifier Type: -

Identifier Source: org_study_id