Clinical trial · Interventional
The First-line Treatment of RCLM With RAS Mutation Was Local Short-course Radiotherapy (SCRT) + PD-1+ Standard Therapy
NCT05640726CI-TRIAL-00062544unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Calcium folinate | Drug | Immunomodulatory Oligonucleotide | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| PD-1 | Drug | — | UNRESOLVED |
| SCRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- (SCRT) followed by PD-1+ standard therapy
- interventionNames
- Drug: PD-1
- Radiation: SCRT
- Drug: Bevacizumab
- Drug: Oxaliplatin
- Drug: Calcium folinate
- Drug: 5-fluorouracil
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
- up to 36 months
- description
- The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).
Secondary outcomes (1)
- measure
- objective response rate
- timeFrame
- every 3 months (up to 36 months）
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.