Phase II Clinical Trial for PD-1 inhibitor with Metronomic chemotherapy for Advanced Colorectal Cancer with microsatellite stability (MSS)

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2000032079

Enrollment

Unknown

Registered

2020-04-19

Start date

2020-04-07

Completion date

Unknown

Last updated

2020-04-20

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

Conditions

Advanced Colorectal Cancer

Interventions

Case series:fPD-1 inhibitor with Metronomic chemotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with colorectal adenocarcinoma of p-mmr type confirmed by pathology (histology or cytology), the results of tumor immunohistochemistry were: MLH1 +, MSH2 +, MSH6 +, PMS2 +; 2. Subjects who have received two or more standard chemotherapy schemes, and the scheme drugs include oxaliplatin, irinotecan and fluorouracil; 3. Aged 18-75 years old; 4. ECoG score 0-1; 5. Blood routine test and liver and kidney function meet the following conditions: neutrophil count >1.5*10^9/L, hemoglobin concentration >90g/L, platelet count > 80*10^9/L, ALT and AST 3 months; 7. Patients with at least one tumor focus meeting the criteria of SBRT; 8. Patients who have at least one tumor focus without radiotherapy and are measurable according to the RECIST 1.1 standard; 9. Patients willing to receive long-term follow-up, provide tumor tissue samples, and provide blood samples before and after treatment; 10. Patients willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to the test drug; 2. Patients who have previously received PD-1 / PD-L1 treatment; 3. Patients with active infection requiring systemic treatment; 4. Patients diagnosed as immune deficiency or undergoing systemic steroid therapy; 5. Patients with active autoimmune diseases who need systemic treatment in the past two years (using immunomodulators, corticosteroids or immunosuppressive drugs); 6. Patients with known mental illness or drug abuse disorder that may interfere with the trial; 7. Pregnant and lactating patients; 8. Patients with poor compliance.

Design outcomes

Primary

Measure	Time frame
Overall survival, OS;Progression-free survival, PFS;	—

Secondary

Measure	Time frame
Obejective response rate, ORR;Safety;	—

Countries

China

Contacts

Public ContactYulong He

The seventh Affiliated Hospital of Sun Yat sen University

heyulong@mail.sysu.edu.cn+86 13822288293

Outcome results

None listed

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