Conversion Therapy of Sintilimab in Combination With Fruquintinib and Chemotherapy Versus Sintilimab and Chemotherpay in Stage IV Gastric Cancer

NCT06454435 | Not Yet Recruiting Phase 2

• 1 other identifier: E20231573
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, open-label, phase 2 clinical study aiming to evaluate the feasibility and efficacy of sintilimab (PD-1 inhibitor) in combination of fruquintinib and chemotherapy (S-1 plus nab-paclitaxel) versus sintilimab and chemotherapy as conversion therapy in patients with stage IV gastric cancer in China.

Conditions

Gastric Cancer; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• R0-surgery conversion rate

  The proportion of patients who underwent R0 surgery among all efficacy evaluable patients.

  about 3 years

Secondary Outcomes (8)

• Pathological complete response (pCR)

  about 3 years

• Major pathological response rate (MPR)

  about 3 years

• Rate of downstaging

  about 3 years

• Objective response rate (ORR)

  about 3 years

• Disease control rate (DCR)

  about 3 years

Study Arms (2)

Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel

EXPERIMENTAL

Drug: Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel

Sintilimab + S-1 plus nab-paclitaxel

ACTIVE COMPARATOR

Drug: Sintilimab + S-1 plus nab-paclitaxel

Interventions

Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel DRUG

Drug: Sintilimab Sintilimab 200mg, D1, IV, Q3W 4-8 cycles Drug: Fruquintinib Fruquinitinib 4mg/d, QD, PO, D1-D14, Q3W 4-8 cycles Drug: S-1 BSA\<1.25 m2, 40mg twice/day; BSA 1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, D1-D14, Q3W 4-8 cycles Drug: Nab-paclitaxel * without peritoneal metastases: 260 mg/m2, IV, D1 for 3h, Q3W 4-8 cycles; * with peritoneal metastases: 80mg/m2 IP, plus 180mg/m2, IV, D1, Q3W 4-8 cycles.

Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel

Sintilimab + S-1 plus nab-paclitaxel DRUG

Drug: Sintilimab Sintilimab 200mg, D1, IV, Q3W 4-8 cycles Drug: S-1 BSA\<1.25 m2, 40mg twice/day; BSA 1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, D1-D14, Q3W 4-8 cycles Drug: Nab-paclitaxel * without peritoneal metastases: 260 mg/m2, IV, D1 for 3h, Q3W 4-8 cycles; * with peritoneal metastases: 80mg/m2 IP, plus 180mg/m2, IV, D1, Q3W 4-8 cycles.

Sintilimab + S-1 plus nab-paclitaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed gastric/gastroesophageal junction adenocarcinoma through gastroscopy.
• Ages: 18-70 Years (concluding 18 and 70 Years)
• Life expectancy ≥3 months.
• Treatment-naive Stage IV (clinical staging, AJCC 8th) unresectable patients, no prior antitumor therapy (including radiation, chemotherapy, targeted therapy or immunotherapy, etc.).
• The Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0-1.
• Preoperative examinations using CT, MRI, PET-CT, etc., indicating only one unresectable factor OR peritoneal metastasis with another unresectable factor, such as:
• N3 lymph node metastasis, mainly referring to group 16 lymph node metastasis.
• Extensive or bulky lymph nodes (D2)
• Locally advanced T4b.
• Hepatic metastases (H1): ≤5 lesions with a total diameter ≤8cm.
• Peritoneal metastasis (CY1, P1).
• Ovarian metastasis (Krukenberg tumor).
• Physically fit for major abdominal surgery.
• Adequate organ and marrow function, defined as:
• Hematological status: Absolute neutrophil count (ANC) ≥1.5×10\^9/L; Platelet count (PLT) ≥100×10\^9/L; Hemoglobin (HGB) ≥9.0 g/dL.

You may not qualify if:

• HER-2 positive patients or willing to receive Trastuzumab.
• Endoscopic signs of active bleeding from the lesion.
• Patients with moderate/large volume of ascites.
• Near-obstruction at the cardia or pylorus affecting feeding and gastric emptying or difficulty swallowing tablets.
• Concurrently suffering from other serious illnesses that are difficult to control (Severe uncontrolled recurrent infections, atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction measurement under 50%, uncontrolled hypertension, renal insufficiency, symptomatic peripheral neuropathy, and NCI classification \>II)
• Has already on other medications prior to enrollment or could not be assured of compliance after enrollment.
• Allergy to any drugs in the regimen.
• Women who are pregnant or breastfeeding and have childbearing potential but are not taking adequate contraceptive measures.
• Organ transplant recipients requiring immunosuppression.
• Patients without decision-making capacity or with psychiatric disorders.
• Systemic treatment with Chinese herbal anti-tumor or immunomodulatory drugs (including thymosin, interferons, interleukins) within 2 weeks before the first dose.
• Use of immunosuppressive drugs within 4 weeks before the first study treatment, excluding local steroids or physiological doses of systemic steroids.
• Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment.
• Has a diagnosis of autoimmune disease within the previous 2 years (Patients with vitiligo, psoriasis, alopecia areata, or Graves' disease who do not require systemic therapy within the last 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and type I diabetes mellitus requiring only insulin replacement therapy are eligible for enrollment).
• Known history of primary immunodeficiency.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 210000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

sintilimab; S 1 (combination); 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Han Liang, MD

CONTACT

18622221082; tjlianghan@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 12, 2024

Record last verified: 2024-05

Locations

CN (1)