Fruquintinib and Albumin-paclitaxel Combined With or Without PD-1 Antibody in 2nd-line Treatment of G/GEJ Adenocarcinoma

NCT06417892 | Recruiting FDA Drug

• 1 other identifier: NCC4594
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the efficacy and safety of fruquintinib and albumin-paclitaxel combined with or without PD-1 antibody in the second-line treatment of advanced gastric/gastroesophageal junction adenocarcinoma that failed to be treated by anti-PD-1 /PD-L1 regimen

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression free survival

  2 years

Secondary Outcomes (5)

• ORR

  2 years

• DCR

  2 years

• DoR

  2 years

• OS

  2 years

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  2 years

Study Arms (2)

Fruquintinib + albumin paclitaxel

Fruquintinib combined with albumin paclitaxel

Drug: Fruquintinib; Drug: albumin paclitaxel

Fruquintinib + albumin paclitaxel + PD-1 antibody

Fruquintinib, albumin paclitaxel combined with PD-1 antibody

Drug: PD-1inhibitor; Drug: Fruquintinib; Drug: albumin paclitaxel

Interventions

PD-1inhibitor DRUG

PD-1 antibody was selected according to first-line drug use

Also known as: PD-1 antibody

Fruquintinib + albumin paclitaxel + PD-1 antibody

Fruquintinib DRUG

a small molecular anti-tumor angiogensis drug

Fruquintinib + albumin paclitaxel; Fruquintinib + albumin paclitaxel + PD-1 antibody

albumin paclitaxel DRUG

a kind of cytotoxic chemotherapy drug

Also known as: nab-paclitaxel

Fruquintinib + albumin paclitaxel; Fruquintinib + albumin paclitaxel + PD-1 antibody

Eligibility Criteria

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

Study Population

Patients with advanced gastric/gastroesophageal junction adenocarcinoma who failed treatment with anti-PD-1 /PD-L1 regimen.

You may qualify if:

• Have fully understood the study and voluntarily signed the informed consent;
• Age ≥18 years old;
• Pathologically confirmed advanced gastric/gastroesophageal junction adenocarcinoma with at least one systemic treatment;
• Frontline experienced exposure to immune drugs (including exposure to PD-1 drugs in the neoadjuvant, adjuvant, and systemic treatment stages; For patients with metastasis and recurrence within 6 months after the end of adjuvant/neoadjuvant system treatment, the above-mentioned treatment is first-line treatment);
• ECOG's physical condition was 0-1, and did not deteriorate within 7 days;
• BMI≥18;
• Expected survival ≥3 months;
• The functions of vital organs meet the following requirements (the use of any blood components and cell growth factors is not allowed within the first 14 days of enrollment) a) Absolute neutrophil count ≥1.5×109/L, white blood cell ≥4.0×109/L; b) Platelet ≥100×109/L; c) Hemoglobin ≥90g/L; d) Total bilirubin TBIL≤1.5 times ULN; e)ALT and AST≤2.5 times ULN (up to 5 times in patients with liver metastasis); f) Urea/urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN (and creatinine clearance (CCr) ≥ 50mL/min); g) Left ventricular ejection fraction (LVEF) ≥50%; h)Fridericia's corrected QT interval (QTcF) \<470 ms. i) INR≤1.5 x ULN, APTT≤1.5 x ULN.
• Women of childbearing age need to take effective contraceptive measures;
• Good compliance, cooperate with follow-up;

You may not qualify if:

• Failure to comply with the study protocol or study procedure;
• Previous treatment with VEGFR inhibitors;
• Previously received paclitaxel therapy (except for those who received paclitaxel therapy in neoadjuvant or adjuvant therapy, and the treatment ended more than 6 months after the progression of the disease);
• Known HER-2 positive patients;
• Receive live vaccine within 4 weeks prior to enrollment or possibly during the study period;
• Had other malignancies within 5 years prior to enrollment, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
• Had active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;
• Previously received allogeneic bone marrow transplantation or organ transplantation;
• Subjects who are allergic to the investigational drug or any of its adjuncts;
• Electrolyte abnormalities identified by the investigator as clinically significant;
• Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg;
• Had any disease or condition affecting drug absorption before enrollment, or the patient could not take the drug orally;
• Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unresectable tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment;
• Patients with significant evidence or history of bleeding tendency (hemorrhage \>30 mL within 3 months, accompanied by hematemesis, stool, and blood in the stool), hemoptysis (\>5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months prior to enlistment;
• Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; Congestive heart failure New York Heart Association (NYHA) Grade \>2; Ventricular arrhythmias requiring medical treatment; LVEF (left ventricular ejection fraction) \<50%;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

spartalizumab; HMPL-013; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

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

Study Officials

• LIN YANG, Doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LIN YANG, Doctor

CONTACT

010-87788145; linyangcicams@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 16, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

CN (1)