Safety and efficacy evaluation of BCc1 nanomedicine on patients with Gastric Cancer

Safety and efficacy evaluation of BCc1 nanomedicine designed based on Nanochelating technology on patients with metastatic and non-metastatic Gastric Cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017101935423N1

Enrollment

120

Registered

2017-10-19

Start date

2017-07-23

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer. Malignant neoplasm of stomach

Interventions

Intervention 1: Intervention1: BCc1 nanomedicine dosage for non-metastatic patients is 1500 mg/day and for metastatic patients is 3000 mg/day

3 times daily and every 8 hours

Duration for use of BCc1 nanomedicine for metastatic patients 4 months and non-metastatic patients 10 months after Intervention

Design and synthesis of BCc1 nanomedicine has don by Sodour Ahrar Shargh Knowledge-based Company and packaging by tehrandarou Company. Intervention 2: Intervention 2: The administration of placebo c

Placebo dosage for non-metastatic patients is 1500 mg / day

Placebo dosage for metastatic patients is 3000 mg / day

duration of use for metastatic patients 4 months and non-metastatic patients 10 months after intervention

The placebo packaging has done by Tehrandarou Company.

Treatment - Drugs

Placebo

Intervention1: BCc1 nanomedicine dosage for non-metastatic patients is 1500 mg/day and for metastatic patients is 3000 mg/day

Design and synthesis of BCc1 nanomedicine has don by Sodour Ahrar Shargh Knowledge-based Company and packaging by tehrandarou Company.

Intervention 2: The administration of placebo capsule, which is similar in shape and size to the capsule of the main drug

Eligibility

Sex/Gender

All

Age

25 Years to 85 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with metastatic and non-metastatic Gastric Cancer who have signed the informed consent form. Exclusion criteria: Patient's declining to continue taking nano-medicines; Witnessing adverse symptoms in the patient after taking the nano-medicines.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Safety. Timepoint: Non-metastatic patients 10 months after intervention; Metastatic patients 4 monthsafter intervention. Method of measurement: Qualitative assessment is based on the standard form.;Quality of Life. Timepoint: Non-metastatic patients 4 months after intervention; Metastatic patients 1/5 monthsafter intervention. Method of measurement: A standard quality of life questionnaire for patients with Gastric Cancer EORTC QLQ-STO22.	—

Measure

Time frame

Safety. Timepoint: Non-metastatic patients 10 months after intervention; Metastatic patients 4 monthsafter intervention. Method of measurement: Qualitative assessment is based on the standard form.;Quality of Life. Timepoint: Non-metastatic patients 4 months after intervention; Metastatic patients 1/5 monthsafter intervention. Method of measurement: A standard quality of life questionnaire for patients with Gastric Cancer EORTC QLQ-STO22.

—

Secondary

Measure	Time frame
Metastasis. Timepoint: 10 months after intervention. Method of measurement: Laboratory examinations and abdominal and pelvic CT scans before and after study.;Survive. Timepoint: For metastatic patients 4 months after intervention and for non-metastatic patients 10 months after intervention. Method of measurement: Kaplan-Meier Estimator.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Hafizi

Cancer Research Centre, Shahid Beheshti University of Medical Sciences

m.hafizi6060@gmail.com;+98 212274800

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 3, 2026