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A comparative randomized clinical trial evaluating the effect of combination chemotherapy regimens, Pembrolizumab + Capecitabine versus Capecitabine alone as second-line treatment, on the quality of life and survival rates of patients with treatment-resistant gastric cancer

A comparative randomized clinical trial evaluating the effect of combination chemotherapy regimens, Pembrolizumab + Capecitabine versus Capecitabine alone as second-line treatment, on the quality of life and survival rates of patients with treatment-resistant gastric cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240622062212N1
Enrollment
32
Registered
2025-11-10
Start date
2025-12-22
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Gastric cancer,capecitabin.pembrolizumab.

Interventions

Intervention group:.

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Having stomach cancer that is resistant to first-line chemotherapy treatments Providing informed written consent to participate in the study

Exclusion criteria

Exclusion criteria: Patients’ unwillingness to continue participating in the study Death of the patient from causes other than stomach cancer before the end of the study follow-up period

Design outcomes

Primary

MeasureTime frame
1.Quality of Life (QoL): Assessed using a validated questionnaire (e.g., EORTC QLQ-C30) at baseline and during follow-up.2.Overall Survival (OS): Time from randomization to death from any cause, measured during the study follow-up period. Timepoint: 1.Quality of Life (QoL): Assessed at baseline (before starting second-line treatment), then every 3 months during follow-up, until the end of the study.2.Overall Survival (OS): Measured from the date of randomization until death from any cause or the end of the follow-up period (up to 24 months). Method of measurement: 1.Quality of Life (QoL): Measured using the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).2.Overall Survival (OS): Measured as the time interval between randomization and death from any cause, recorded through medical records and follow-up visits.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSara teihou jorshari

Iran University of Medical Sciences

Sara.teihou@gmail.com+98 911 310 7343

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026