WHO ICTRP trial
A Non-comparative clinical study of Toripalimab in Indian patients with…
CTRI/2024/12/077942 · Clinical Trials Registry India (CTRI) · Recruiting
Key facts
| Trial ID | CTRI/2024/12/077942 |
|---|---|
| Public title | A Non-comparative clinical study of Toripalimab in Indian patients with recurrent or metastatic Nasopharyngeal carcinoma as monotherapy or along with standard chemotherapy (cisplatin and gemcitabine) |
| Scientific title | A phase 4, multicenter, noncomparative, open-label, two cohort study evaluating the safety and efficacy of intravenously administered toripalimab in the treatment of Indian patients with recurrent or metastatic nasopharyngeal carcinoma |
| Primary sponsor | Dr. Reddys Laboratories Ltd. |
| Secondary sponsors | Dr Reddys Laboratories Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | Phase 4 |
| Countries | India |
| Conditions | Health Condition 1: C119- Malignant neoplasm of nasopharynx,unspecified |
| Interventions | Intervention1: Toripalimab: 240 mg fixed-dose IV infusion on Day 1 of each 21-day cycle for cohort-1 3 mg/kg IV infusion on Day 1 of each 14-day cycle for cohort-2 Control Intervention1: Not Applicable: Not Applicable |
| Registration date | Nov 12, 2024 |
| Target size | 50 |
| Secondary IDs | TP-02-001 Version 2.0 dated 03 Oct 2024 |
| Registry page | ctri.nic.in |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: