Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Advanced G/GEJ Cancer

NCT05853172 | Unknown Phase 2

• 1 other identifier: E20221047
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-arm, open-label，single-center, phase II study, aiming to to evaluate the surgical conversion feasibility of AK104 combined with apatinib, paclitaxel and S-1 in unresectable stage IV G/GEJ cancer.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• R0 surgical conversion rate

  up to 2 years

Secondary Outcomes (7)

• R0 resection rate

  up to 2 years

• Pathological complete response (pCR)

  up to 2 years

• Pathological major response (MPR)

  up to 2 years

• Objective response rate (ORR)

  up to 2 years

• Disease control rate (DCR)

  up to 2 years

Study Arms (1)

AK104 plus apatinib, paclitaxel and S-1

EXPERIMENTAL

AK104 (10mg/kg, iv, Q3W) is combined with apatinib (250mg, po, qd), paclitaxel (non-peritoneal metastasis: 130mg/m2, iv, D1; peritoneal metastasis: 90mg/m2, iv, 40mg/m2, ip, D1) and S-1(60mg, po, bid, D1-D14) for up to 6 cycle for up to 6 cycles.

Drug: AK104; Drug: Apatinib; Drug: Paclitaxel; Drug: S-1

Interventions

AK104 DRUG

Subjects will receive AK104 until disease progression or for up to 6 cycles.

AK104 plus apatinib, paclitaxel and S-1

Apatinib DRUG

Subjects will receive apatinib until disease progression or for up to 6 cycles.

AK104 plus apatinib, paclitaxel and S-1

Paclitaxel DRUG

Subjects will receive paclitaxel until disease progression or for up to 6 cycles.

AK104 plus apatinib, paclitaxel and S-1

S-1 DRUG

Subjects will receive S-1 until disease progression or for up to 6 cycles.

AK104 plus apatinib, paclitaxel and S-1

Eligibility Criteria

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

You may qualify if:

• Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.
• Clinically diagnosed unresectable stage IV gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma by CT/MRI/Positron Emission Tomography (PET) -CT.
• Not received prior systemic therapy for stage IV G/GEJ adenocarcinoma
• At least one measurable tumor lesion per RECIST v1.1;
• Major organ functions are adequate;
• Expected survival is ≥ 3 months;
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1;

You may not qualify if:

• Human Epidermal GrowthFactor Receptor 2 (HER2)-positive G/GEJ adenocarcinoma;
• Previously received immune checkpoint inhibitors, including but not limited to programmed death 1 (PD-1) inhibitors and cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors;
• Central nervous system, lung, or bone metastases;
• Known history of active or autoimmune disease;
• Known history of other malignancies;
• Known history of severe cardiovascular and cerebrovascular diseases;
• Known history of gastrointestinal bleeding within the past 3 months or significant tendency to gastrointestinal bleeding;
• Active infection or fever of unknown origin;
• Known history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function;
• Known history of immunodeficiency, positive HIV antibody (HIVAb) test, or other acquired or congenital immunodeficiency disorder, or active hepatitis;
• Known history of mental disorder or psychoactive substance abuse;
• Hypersensitivity to the drugs of this regimen;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib; Paclitaxel; S 1 (combination)

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Han Liang, MD

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Han Liang, MD

CONTACT

18622221082; tjlianghan@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 10, 2023
• Study Start: March 21, 2023
• Primary Completion: March 21, 2025
• Study Completion: December 21, 2025
• Last Updated: May 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)