The First-line Treatment of RCLM With RAS Mutation Was Local Short-course Radiotherapy (SCRT) + PD-1+ Standard Therapy

Rectal Cancer Clinical Trial

Official title:

The First-line Treatment of RCLM With RAS Mutation Was Local Short-course Radiotherapy (SCRT) + PD-1+ Standard Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05640726
• Other study ID #: TCO002
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2023
• Est. completion date: May 1, 2026

Study information

• Verified date: November 2022
• Source: Fujian Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore the efficacy and safety of radiotherapy followed by PD-1+ standard chemotherapy in the first-line treatment of initial unresectable rectal cancer liver metastases

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the rectum;

• The clinical stage evaluated by MRI was T3-4 and/or N+ and M1a(only liver metastasis);

• ECOG PS 0-2;

• CHild Pugh A;

• Estimated survival =3 months;

• Women of childbearing age should comply with contraceptive measures if pregnancy test is negative;

• Adequate organ and bone marrow functions, ecg, blood, biochemical and other basic tests are not contraindications of chemotherapy;

• Adherence to scheduled visits, treatment plans, laboratory tests, and other study procedures Willingness and ability.

Exclusion Criteria:

• Pregnant or lactating women;

• No previous antitumor therapy;

• No previous liver local therapy;

• No contraception during the reproductive period;

• patients known to have a history of allergy to any study drug, similar drug or excipient;

• Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;

• Patients with a history of thromboembolism, except those caused by PICC;

• Patients with active infection;

• Other conditions that the investigator determines are not suitable for inclusion in the study.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• PD-1
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks

Radiation:
• SCRT
Radiotherapy dose: 5×5 Gy

Drug:
• Bevacizumab
Participants will receive bevacizumab,5mg/kg,intravenously over 60 - 90 minutes, day 1 of every 2 weeks
• Oxaliplatin
Participants will receive Oxaliplatin,85mg/m2,day1
• Calcium folinate
Participants will receive calcium folinate ,400mg/m2,day1
• 5-fluorouracil
Participants will receive 5-fluorouracil ,400mg/m2,day1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival	The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).	up to 36 months
Secondary	objective response rate	Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).	every 3 months (up to 36 months)