Efficacy and safety of Thymosin alpha 1 combined with anti-PD-1 and Apatinib in advanced gastric cancer patients failed to second line treatment

Efficacy and safety of Thymosin alpha 1 combined with anti-PD-1 and Apatinib in advanced gastric cancer patients failed to second line treatment:a multi-center,open labelled,randomized,controlled trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900025367

Enrollment

Unknown

Registered

2019-08-25

Start date

2019-08-21

Completion date

Unknown

Last updated

2019-08-27

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

Conditions

Advanced Gastric Cancer

Interventions

1:Thymosin alpha 1 combined with PD-1 antibody and Apatinib

2:PD-1 and Apatinib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or female, aged above 18 years; 2. ECOG 0-1; 3. Pathological diagonosed of advanced gastric cancer or gastric esophageal junction adenocarcinoma; 4. According to iRECIST criteria, there is at least one measurable lesion; 5. Atlease 2 weeks apart from local palliative radiotherapy to randomization; 6. Advanced gastric cancer failed to 2 or more lines treatment.

Exclusion criteria

Exclusion criteria: 1. Known allergic or untolerant to Apatinib,PD-1 antibody or Thymosin alpha 1; 2. Uncontrolled variety syndromes; 3. With unsolved adverse event related with PD-1 therapy.

Design outcomes

Primary

Measure	Time frame
PFS;ORR;AE incident rate;	—

Secondary

Measure	Time frame
DCR;OS;	—

Countries

China

Contacts

Public ContactJin Li

Shanghai Dongfang Hospital

lijin@csco.org.cn+86 13761222111

Outcome results

None listed

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